Optetrak LogicRecalls & reported problems across all models
Exactech, Inc. · 408 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Optetrak Logic model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3,306
- Deaths reported
- 1
- Injuries reported
- 3,293
- Recalls
- 3
We found 408 models of Optetrak Logic by Exactech, Inc. in the FDA's device registry (GUDID). Together they are named in 3,306 adverse event reports in the FDA's MAUDE database, received between Jul 2, 2019 and Sep 29, 2026 — classified as 1 death, 3,293 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (2,072 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Optetrak Logic recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 21, 2023Open, Classified
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Z-0584-2024 · Root cause: Packaging change control · Recall details · FDA record ↗
- Nov 21, 2023Open, Classified
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Z-0583-2024 · Root cause: Packaging change control · names 3 of these models · Recall details · FDA record ↗
- Aug 30, 2021Open, Classified
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Z-0021-2022 · Root cause: Process control · names 299 of these models · Recall details · FDA record ↗
Most reported Optetrak Logic problems
Device problems
- Naturally Worn2,072
- Loosening of Implant Not Related to Bone-Ingrowth831
- Unstable715
- Adverse Event Without Identified Device or Use Problem546
- Insufficient Device Problem Information332
- Mechanical Problem120
- Fracture68
- Appropriate Device Problem Term/Code Not Available36
Patient problems
- Failure of Implant1,625
- Pain1,346
- Osteolysis1,098
- Synovitis807
- Swelling/ Edema771
- Joint Laxity766
- Insufficient Information658
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available589
Optetrak Logic models
408 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Optetrak Logic 02-012-35-5009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls90 reports
- Optetrak Logic 02-012-35-4009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall106 reports
- Optetrak Logic 02-012-35-2009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall96 reports
- Optetrak Logic 02-012-35-3009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall87 reports
- Optetrak Logic 02-012-35-3011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall78 reports
- Optetrak Logic 02-012-35-4011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall78 reports
- Optetrak Logic 02-012-47-5009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls23 reports
- Optetrak Logic 02-012-35-2011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall70 reports
- Optetrak Logic 02-012-47-3011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls9 reports
- Optetrak Logic 02-012-44-4009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall58 reports
- Optetrak Logic 02-012-47-5011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls6 reports
- Optetrak Logic 02-012-35-5011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall50 reports
- Optetrak Logic 02-012-44-3009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall50 reports
- Optetrak Logic 02-012-44-2009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall49 reports
- Optetrak Logic 02-012-35-4013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall46 reports
- Optetrak Logic 02-012-44-2011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall45 reports
- Optetrak Logic 02-012-44-4011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall44 reports
- Optetrak Logic 02-012-35-3509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall42 reports
- Optetrak Logic 02-012-44-3011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall42 reports
- Optetrak Logic 02-012-35-3013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall39 reports
- Optetrak Logic 02-012-35-3511Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall39 reports
- Optetrak Logic 02-012-44-5009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall1 death39 reports
- Optetrak Logic 02-012-44-5011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall39 reports
- Optetrak Logic 02-012-35-2509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall36 reports
- Optetrak Logic 02-012-44-4013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall35 reports
- Optetrak Logic 02-012-35-2013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall31 reports
- Optetrak Logic 02-012-47-4009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall29 reports
- Optetrak Logic 02-012-35-2511Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall27 reports
- Optetrak Logic 02-012-44-3013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall27 reports
- Optetrak Logic 02-012-35-4015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall24 reports
- Optetrak Logic 02-012-35-5013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall23 reports
- Optetrak Logic 02-012-44-4015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall23 reports
- Optetrak Logic 02-012-49-4011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall23 reports
- Optetrak Logic 02-012-47-2509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall21 reports
- Optetrak Logic 02-012-44-2013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall21 reports
- Optetrak Logic 02-012-44-5013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall20 reports
- Optetrak Logic 02-012-49-4009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall20 reports
- Optetrak Logic 02-012-44-3015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall19 reports
- Optetrak Logic 02-012-47-3009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall19 reports
- Optetrak Logic 02-012-51-3009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall18 reports
- Optetrak Logic 02-012-51-5009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall18 reports
- Optetrak Logic 02-012-35-1011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall17 reports
- Optetrak Logic 02-012-35-1009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall16 reports
- Optetrak Logic 02-012-44-3511Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall16 reports
- Optetrak Logic 02-012-49-2009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall16 reports
- Optetrak Logic 02-012-48-4009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall16 reports
- Optetrak Logic 02-012-35-3015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall15 reports
- Optetrak Logic 02-012-49-3509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall15 reports
- Optetrak Logic 02-012-35-3513Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall14 reports
- Optetrak Logic 02-012-48-2009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall14 reports
- Optetrak Logic 02-012-49-3011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall14 reports
- Optetrak Logic 02-012-51-4009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall14 reports
- Optetrak Logic 02-012-49-2011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall13 reports
- Optetrak Logic 02-012-35-2015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall12 reports
- Optetrak Logic 02-012-48-3509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall12 reports
- Optetrak Logic 02-012-49-3511Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall12 reports
- Optetrak Logic 02-012-47-2009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall12 reports
- Optetrak Logic 02-012-48-3009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall12 reports
- Optetrak Logic 02-010-01-0240Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer61 reports
- Optetrak Logic 02-012-48-2509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall11 reports
- Optetrak Logic 02-012-49-2509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall11 reports
- Optetrak Logic 02-012-44-2513Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall11 reports
- Optetrak Logic 02-012-44-3513Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall11 reports
- Optetrak Logic 02-012-44-3515Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall11 reports
- Optetrak Logic 02-012-49-3009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall11 reports
- Optetrak Logic 02-012-51-2009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall11 reports
- Optetrak Logic 02-012-51-4011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall11 reports
- Optetrak Logic 02-012-35-2513Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Optetrak Logic 02-012-47-1509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Optetrak Logic 02-012-44-2015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Optetrak Logic 02-012-44-2511Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Optetrak Logic 02-012-44-3509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Optetrak Logic 02-012-49-2013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Optetrak Logic 02-012-48-5009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Optetrak Logic 02-012-51-2509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Optetrak Logic 02-012-51-3011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Optetrak Logic 02-012-35-6011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak Logic 02-012-44-1009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak Logic 02-012-44-2515Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak Logic 02-012-44-5015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak Logic 02-012-47-3013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak Logic 02-012-48-3011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak Logic 02-012-49-4013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak Logic 02-012-49-5009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak Logic 02-012-51-4013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak Logic 02-012-47-3509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Optetrak Logic 02-012-44-1011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Optetrak Logic 02-012-47-4011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Optetrak Logic 02-010-01-0340Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer57 reports
- Optetrak Logic 02-012-48-1509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak Logic 02-012-49-2513Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak Logic 02-012-44-2509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak Logic 02-012-48-2011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak Logic 02-012-49-3013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak Logic 02-012-48-4011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak Logic 02-012-49-5011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak Logic 02-012-51-5011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak Logic 02-012-35-2515Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Optetrak Logic 02-012-35-5015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Optetrak Logic 02-012-35-6009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
Recent Optetrak Logic adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Loosening of Implant Not Related to Bone-Ingrowth
Patient problems: Insufficient Information
MAUDE report 50933386 ↗InjuryAug 18, 2026Naturally Worn
It was reported via legal notification that a patient underwent initial left total knee arthroplasty. The patient alleges having sustained injuries because of the recalled product have resulted in ongoing treatment. There is no other patient demographic or medical history available. Further patient impact is unknown. No additional information is available.
Patient problems: Insufficient Information
MAUDE report 50302279 ↗InjuryAug 11, 2026Naturally Worn
Patient problems: Pain; Unspecified Musculoskeletal problem
MAUDE report 50208180 ↗InjuryAug 11, 2026Loosening of Implant Not Related to Bone-Ingrowth
As reported, approximately 6 years and 6 months post the initial left total knee arthroplasty, the patient presented to the surgeon's office with stiffness, pain and dissatisfaction with their total knee. The patient has a recalled poly. The patient was revised to competitor devices. The femoral component was loose and not well fixed. Images provided show wear of the liner. There was no reported breakage of a device. There was a surgical delay/prolongation of 30-45 minutes due to switching to a total revision. The patient was last known to be in stable condition following the event.
Patient problems: Pain; Unspecified Musculoskeletal problem
MAUDE report 50208136 ↗InjuryAug 11, 2026Loosening of Implant Not Related to Bone-Ingrowth
Report #2 of 3 for this event.It was reported this patient had an initial left total knee arthroplasty. Subsequently, four (4) years, nine (9) months later, the patient underwent a revision procedure due loosening as a result of polyethylene prosthesis wear. All devices were revised. The Patient was last known to be stable following the event. Images of the explants were provided. No additional information is available.
Patient problems: Insufficient Information
MAUDE report 50203104 ↗MalfunctionAug 4, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50129791 ↗InjuryAug 4, 2026Loosening of Implant Not Related to Bone-Ingrowth
Patient problems: Pain
MAUDE report 50127348 ↗InjuryAug 4, 2026Naturally Worn
It was reported that this patient underwent a right knee replacement. Subsequently, the patient reported pain. The tibial insert and patellar component are subject to the recall. Evaluation also identified a loose femoral component. The patient was last known to be in stable condition following the event. No further information is available.
Patient problems: Pain
MAUDE report 50127209 ↗InjuryAug 3, 2026Naturally Worn
As reported, approximately 10 years and 4 months post the initial right total knee arthroplasty, the patient was revised due to tibial and patellar wear. The patella poly showed significant wear with mild osteolysis of the bone; no bone graft required. There was moderate wear on the tibial insert. There was no reported breakage of a device or surgical delay/prolongation. The patient was last known to be in stable condition following the event.
Patient problems: Osteolysis
MAUDE report 50113634 ↗InjuryJul 28, 2026Loosening of Implant Not Related to Bone-Ingrowth
Report #2 of 2 for this event.It was reported this patient underwent a left total knee arthroplasty. Subsequently, four (4) years, nine (9) months later, the patient was revised to a competitor's construct due to prosthesis wear of the polyethylene component and loosening of the femoral component. A revision operative report was provided. Intraoperatively, the patella component was noted to be well fixed. The femoral component was easily removed without much bone loss. Osteolysis was observed in the tibia. After trialing new components, an anterior cortical fracture was observed. This required 2 cables to be placed. After this there is no fracture gapping. The patient was revised to a competitor's construct. The patient was awoken from anesthesia and transferred to the recovery room in stable condition. Additionally, it is reported via legal documentation, the patient has and continues to experience pain and discomfort, gait impairment, poor balance, difficulty walking, component part loosening, bone loss and other injuries presently undiagnosed. No additional information is available.
Patient problems: Ambulation or Postural Difficulties; Osteolysis; Pain; Periprosthetic fracture
MAUDE report 50063037 ↗InjuryJul 28, 2026
According to the information provided, the patient underwent a left total knee replacement surgery. Approximately 12 years and 11 months later, the patient had revision surgery on the left knee. All components were removed. Per the Operative Report, the patient presented with significant mechanical loosening and instability of their left primary total knee prosthesis. This was refractory to comprehensive nonoperative management due to extensive polyethylene wear and osteolysis. Because the patient has filed a long form, it appears that they are alleging prosthesis wear, significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; soft tissue damage; bone loss; and other injuries presently undiagnosed.
Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis
MAUDE report 50058408 ↗InjuryJul 20, 2026Naturally Worn
AS REPORTED, APPROXIMATELY 6 YEARS AND 8 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO MECHANICAL INSTABILITY AND PARTICLE DISEASE ASSOCIATED WITH PET WEAR. THE PATIENT WAS EXPERIENCING CONSTANT PAIN. REPORTED PAIN IN RELATION TO THE TIBIA RADIATING TO THE PRE-TIBIAL REGION. FEELING OF INSTABILITY WITHOUT FALLING TO THE GROUND. INCREASINGLY REPORTS PAIN AND INSTABILITY. PHYSICAL EXAMINATION NOTED A COLD KNEE, INTACT SKIN, MARKED PAIN OVER THE TIBIAL COMPONENT AND LATERAL TIBIAL PLATEAU, MEDIAL LAXITY WITH LIGAMENTOUS ENDPOINT, AND NON-TENSE JOINT EFFUSION. RADIOGRAPHS DEMONSTRATED OSTEOLYSIS OF THE MEDIAL TIBIAL PLATEAU AND MEDIAL FEMORAL CONDYLE. CT FINDINGS NOTED CYSTIC LESIONS INVOLVING BOTH TIBIAL PLATEAUS AND THE TIBIAL KEEL WITH EVIDENCE OF POLYETHYLENE WEAR. INTRAOPERATIVE FINDINGS INCLUDE METALLOSIS INFILTRATION OF QUADRICEPS AND PATELLAR TENDONS, SYNOVIAL HYPERTROPHY WITH FOREIGN-BODY GRANULOMATOUS TISSUE, POLYETHYLENE DEBRIS WITHIN JOINT EFFUSION, WEAR AND PARTIAL FRACTURE OF THE MEDIAL POLYETHYLENE INSERT, FREE POLYETHYLENE FRAGMENTS, CONTAINED LATERAL FEMORAL CONDYLE DEFECT (AORI 2B), CONTAINED LATERAL TIBIAL PLATEAU DEFECT (AORI 2
Patient problems: Cyst(s); Joint Laxity; Joint effusion; Metal Related Pathology; Pain
MAUDE report 25871599 ↗InjuryJul 20, 2026Naturally Worn
AS REPORTED, APPROXIMATELY 6 YEARS AND 8 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO MECHANICAL INSTABILITY AND PARTICLE DISEASE ASSOCIATED WITH PET WEAR. THE PATIENT WAS EXPERIENCING CONSTANT PAIN. REPORTED PAIN IN RELATION TO THE TIBIA RADIATING TO THE PRE-TIBIAL REGION. FEELING OF INSTABILITY WITHOUT FALLING TO THE GROUND. INCREASINGLY REPORTS PAIN AND INSTABILITY. PHYSICAL EXAMINATION NOTED A COLD KNEE, INTACT SKIN, MARKED PAIN OVER THE TIBIAL COMPONENT AND LATERAL TIBIAL PLATEAU, MEDIAL LAXITY WITH LIGAMENTOUS ENDPOINT, AND NON-TENSE JOINT EFFUSION. RADIOGRAPHS DEMONSTRATED OSTEOLYSIS OF THE MEDIAL TIBIAL PLATEAU AND MEDIAL FEMORAL CONDYLE. CT FINDINGS NOTED CYSTIC LESIONS INVOLVING BOTH TIBIAL PLATEAUS AND THE TIBIAL KEEL WITH EVIDENCE OF POLYETHYLENE WEAR. INTRAOPERATIVE FINDINGS INCLUDE METALLOSIS INFILTRATION OF QUADRICEPS AND PATELLAR TENDONS, SYNOVIAL HYPERTROPHY WITH FOREIGN-BODY GRANULOMATOUS TISSUE, POLYETHYLENE DEBRIS WITHIN JOINT EFFUSION, WEAR AND PARTIAL FRACTURE OF THE MEDIAL POLYETHYLENE INSERT, FREE POLYETHYLENE FRAGMENTS, CONTAINED LATERAL FEMORAL CONDYLE DEFECT (AORI 2B), CONTAINED LATERAL TIBIAL PLATEAU DEFECT (AORI 2
Patient problems: Cyst(s); Joint Laxity; Joint effusion; Metal Related Pathology; Pain
MAUDE report 25871504 ↗InjuryJul 20, 2026Crack; Unstable; Naturally Worn
AS REPORTED, APPROXIMATELY 6 YEARS AND 8 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO MECHANICAL INSTABILITY AND PARTICLE DISEASE ASSOCIATED WITH PET WEAR. THE PATIENT WAS EXPERIENCING CONSTANT PAIN. REPORTED PAIN IN RELATION TO THE TIBIA RADIATING TO THE PRE-TIBIAL REGION. FEELING OF INSTABILITY WITHOUT FALLING TO THE GROUND. INCREASINGLY REPORTS PAIN AND INSTABILITY. PHYSICAL EXAMINATION NOTED A COLD KNEE, INTACT SKIN, MARKED PAIN OVER THE TIBIAL COMPONENT AND LATERAL TIBIAL PLATEAU, MEDIAL LAXITY WITH LIGAMENTOUS ENDPOINT, AND NON-TENSE JOINT EFFUSION. RADIOGRAPHS DEMONSTRATED OSTEOLYSIS OF THE MEDIAL TIBIAL PLATEAU AND MEDIAL FEMORAL CONDYLE. CT FINDINGS NOTED CYSTIC LESIONS INVOLVING BOTH TIBIAL PLATEAUS AND THE TIBIAL KEEL WITH EVIDENCE OF POLYETHYLENE WEAR. INTRAOPERATIVE FINDINGS INCLUDE METALLOSIS INFILTRATION OF QUADRICEPS AND PATELLAR TENDONS, SYNOVIAL HYPERTROPHY WITH FOREIGN-BODY GRANULOMATOUS TISSUE, POLYETHYLENE DEBRIS WITHIN JOINT EFFUSION, WEAR AND PARTIAL FRACTURE OF THE MEDIAL POLYETHYLENE INSERT, FREE POLYETHYLENE FRAGMENTS, CONTAINED LATERAL FEMORAL CONDYLE DEFECT (AORI 2B), CONTAINED LATERAL TIBIAL PLATEAU DEFECT (AORI 2
Patient problems: Cyst(s); Joint Laxity; Joint effusion; Metal Related Pathology; Pain
MAUDE report 25871451 ↗InjuryJul 17, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED, FOLLOWING THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT BEGAN HAVING COMPLAINTS ABOUT THEIR RIGHT KNEE. FURTHERMORE, THEY LACERATED THEIR RIGHT ACHILLES TENDON AND COMPLETED 6 MONTHS OF PHYSICAL THERAPY. DURING THIS RECOVERY THEY FELT THEIR RIGHT KNEE WAS MORE SWOLLEN AND PAINFUL, AND THEY FELT UNSTABLE WITH DAILY ACTIVITIES. DESPITE NON-OPERATIVE MANAGEMENT, THEIR FUNCTIONAL STATE DECREASED SIGNIFICANTLY DUE TO WORSENING RIGHT KNEE SYMPTOMS. THEY UNDERWENT A CLINICAL, LABORATORY AND RADIOLOGIC WORKUP THAT WAS NEGATIVE FOR INFECTION. APPROXIMATELY 6 YEARS AND 6 MONTHS POST THE INITIAL RIGHT TOTAL KNEE REPLACEMENT, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. THE SURGEON NOTED THERE WAS MARKED SYNOVITIS ENCOUNTERED WITH TISSUE CHANGES SUGGESTIVE OF OSTEOLYSIS. THE POLYETHYLENE COMPONENT DEMONSTRATED PITTED WEAR AND SOME EVIDENCE OF OXIDATION WITH YELLOWISH DISCOLORATION GROSSLY VISIBLE. THE FEMORAL COMPONENT WAS FOUND TO E GROSSLY LOOSE AND WAS NOTED TO BE DEBONDED FROM CEMENT IN SEVERAL AREAS, INCLUDING THE ANTERIOR FLANGE AND THE LATERAL DISTAL CONDYLE. THERE WAS EVIDENCE OF DAMAGE TO THE BONY ARCHITECTURE NOTED SECONDARY TO OSTEOLYSIS. LARGE AMOUNTS OF
Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Osteolysis; Pain
MAUDE report 25855124 ↗
Other Exactech, Inc. products
- Equinoxe305 models · 2,076 reports · 37 recalls
- Novation184 models · 1,145 reports · 25 recalls
- Optetrak336 models · 1,773 reports · 6 recalls
- Truliant414 models · 1,010 reports · 2 recalls
- Acumatch A Series94 models · 54 reports · 15 recalls
- MCS25 models · 7 reports · 5 recalls
- Alteon135 models · 100 reports · 3 recalls
- Vantage66 models · 110 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page