TruliantRecalls & reported problems across all models
Exactech, Inc. · 414 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Truliant model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,010
- Deaths reported
- 1
- Injuries reported
- 977
- Recalls
- 2
We found 414 models of Truliant by Exactech, Inc. in the FDA's device registry (GUDID). Together they are named in 1,010 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2019 and Sep 29, 2026 — classified as 1 death, 977 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (537 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
Truliant 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-0585-2024 · Root cause: Packaging change control · names 10 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-0023-2022 · Root cause: Process control · names 346 of these models · Recall details · FDA record ↗
Most reported Truliant problems
Device problems
- Naturally Worn537
- Adverse Event Without Identified Device or Use Problem255
- Loosening of Implant Not Related to Bone-Ingrowth200
- Unstable165
- Insufficient Device Problem Information160
- Mechanical Problem27
- Break21
- Appropriate Device Problem Term/Code Not Available11
Patient problems
- Pain511
- Failure of Implant404
- Insufficient Information246
- Swelling/ Edema234
- Joint Laxity206
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available175
- Synovitis160
- Discomfort157
Truliant models
414 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Truliant 02-022-35-3509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls33 reports
- Truliant 02-022-35-3510Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls12 reports
- Truliant 02-022-35-3511Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls9 reports
- Truliant 02-022-35-4511Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls8 reports
- Truliant 02-022-35-1509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls4 reports
- Truliant 02-022-47-2509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls4 reports
- Truliant 02-022-35-3010Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls3 reports
- Truliant 02-022-35-1513Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls1 report
- Truliant 02-022-44-3512Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls0 reports
- Truliant 02-022-35-3009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall48 reports
- Truliant 02-022-35-4009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall34 reports
- Truliant 02-022-35-5009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall1 death23 reports
- Truliant 02-022-35-4011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall20 reports
- Truliant 02-022-35-5011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall19 reports
- Truliant 02-022-35-4013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall18 reports
- Truliant 02-022-35-2509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall17 reports
- Truliant 02-022-35-4509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall17 reports
- Truliant 02-022-35-2511Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall13 reports
- Truliant 02-022-44-3013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall12 reports
- Truliant 02-022-47-3509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall12 reports
- Truliant 02-022-51-3509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall12 reports
- Truliant 02-022-35-3011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Truliant 02-022-44-4013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Truliant 02-022-47-2009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Truliant 02-022-35-2510Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Truliant 02-022-35-3012Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Truliant 02-022-35-4010Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Truliant 02-022-35-5010Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Truliant 02-022-51-3511Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Truliant 02-022-35-3013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Truliant 02-022-44-3511Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Truliant 02-022-47-3009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Truliant 02-022-51-3009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Truliant 02-022-44-3015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Truliant 02-022-44-4009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Truliant 02-022-51-4009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Truliant 02-022-51-4011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Truliant 02-022-51-3510Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Truliant 02-022-35-2010Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Truliant 02-022-35-3515Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Truliant 02-022-35-4012Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Truliant 02-022-35-4512Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Truliant 02-022-35-4513Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Truliant 02-022-35-5013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Truliant 02-022-35-6009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Truliant 02-022-44-3509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Truliant 02-022-44-4011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Truliant 02-022-44-4012Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Truliant 02-022-44-5011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Truliant 02-022-51-4013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Truliant 02-022-51-5009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Truliant 02-022-35-2512Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Truliant 02-022-35-3512Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Truliant 02-022-35-4015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Truliant 02-022-44-2015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Truliant 02-022-44-4509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Truliant 02-022-47-4009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Truliant 02-022-51-3011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Truliant 02-022-51-3517Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Truliant 02-022-51-4015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Truliant 02-022-51-4511Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Truliant 02-022-51-2010Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Truliant 02-022-51-2510Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Truliant 02-022-51-4510Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Truliant 02-022-35-2011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-35-2012Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-35-2515Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-35-3513Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-35-4510Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-35-5012Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-35-5015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-44-2013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-44-2511Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-44-3011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-44-3515Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-44-3517Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-44-5009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-47-3011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-47-4013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-51-2009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-51-2509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-51-3513Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-51-4509Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-51-5011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-51-5013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Truliant 02-022-35-2013Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-35-2015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-35-2513Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-35-4515Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-44-2009Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-44-2011Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-44-3017Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-44-3510Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-44-3519Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-44-4010Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-44-4015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-44-4017Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-44-5012Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-44-5017Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Truliant 02-022-47-2015Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
Recent Truliant 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: Pain
MAUDE report 50936034 ↗InjuryAug 10, 2026Unstable; Naturally Worn
Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Synovitis
MAUDE report 50189478 ↗InjuryJul 29, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that this patient underwent a right knee replacement. Subsequently, the patient was revised. The press-fit femoral component did not achieve adequate fixation. The polyethylene insert was removed, and the femoral component was evaluated and found to be loose. Photographs provided showed evidence wear. The femoral component was removed, and a size 3 CCK femoral component was implanted. The patient was last known to be in stable condition following the event. No further information is available.
Patient problems: Aseptic loosening
MAUDE report 50068205 ↗InjuryJul 17, 2026Naturally Worn
AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT TOTAL KNEE REPLACEMENT. THEY UNDERWENT RIGHT KNEE REVISION SURGERY, APPROXIMATELY 1 YEAR POST PRIMARY PROCEDURE. REVISION OP REPORT NOTED THE SYNOVIAL TISSUE LOOKED HEALTHY, AND THERE WERE NO SIGNS OF MUCUS OR PURULENCE OR SIGNIFICANT SYNOVITIS; HOWEVER, THERE WAS SIGNIFICANT SCAR TISSUE OF THE SYNOVIAL TISSUE. THE PATELLAR BUTTON WAS WELL-FIXED IN A GOOD POSITION. THERE WERE NO DAMAGE OR SIGNS OF DELAMINATION ON GROSS INSPECTION OF THE TIBIAL INSERT. THE COMPONENTS WERE WELL FIXED AND IN APPROPRIATE ALIGNMENT. THE SURGEON NOTED THAT THE PATIENT'S BONE QUALITY WAS QUITE POOR. THERE WERE NO INTRAOPERATIVE FRACTURES. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Arthrofibrosis; Inflammation; Loss of Range of Motion; Pain; Scar Tissue
MAUDE report 25857360 ↗InjuryJul 9, 2026Loss of Osseointegration
REPORT #2 OF 2 FOR THIS EVENT. AS REPORTED, A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ONE (1) YEAR, SEVEN (7) MONTHS LATER, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INADEQUATE OSTEOINTEGRATION OF THE POROUS COMPONENTS. AS A RESULT, THE PATIENT WAS REVISED TO CEMENTED COMPONENTS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL MEDICAL OR CLINICAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Inadequate Osseointegration
MAUDE report 25761438 ↗InjuryMay 19, 2026Loosening of Implant Not Related to Bone-Ingrowth
REPORT #2 OF 2 FOR THIS EVENT. IT WAS REPORTED THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, TWO (2) YEARS LATER THE PATIENT BEGAN TO EXPERIENCE SIGNIFICANT PAIN WITH THE RIGHT KNEE, WAS UNABLE TO WALK, PAIN WITH WEIGHTBEARING AND FLEXION CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE. A REVISION OPERATIVE REPORT WAS PROVIDED. PRE AND POST OPERATIVE DIAGNOSIS' WERE RIGHT PROSTHETIC FLEXION CONTRACTURE AND DEBONDING OF THE FEMORAL COMPONENT. INTRAOPERATIVELY, OSTEOPOROSIS WAS OBSERVED. NO OBVIOUS WEAR TO THE TIBIAL INSERT BUT EASILY REMOVED. THE FEMORAL CANAL CEMENT WAS IN TACT, BUT THE FEMORAL COMPONENT WAS COMPLETELY DEBONDED FROM THE CEMENT. THE PATIENT WAS REVISED TO ANOTHER MANUFACTURER'S KNEE SYSTEM. THE PATIENT WAS THEN TRANSFERRED TO PACU IN STABLE CONDITION. ADDITIONALLY, IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT CONTINUES TO EXPERIENCE SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING AND BONE LOSS. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Contracture; Osteolysis; Pain; Unspecified Musculoskeletal problem
MAUDE report 25224783 ↗InjuryMay 19, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY DUE TO ADVANCED DEGENERATIVE JOINT DISEASE, LEFT KNEE, VARUS DEFORMITY, FLEXION CONTRACTURE. THEY WERE SUBSEQUENTLY REVISED, APPROXIMATELY 3 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT STATES THAT THE PATIENT INDICATED FOR SURGERY DUE TO PAIN, INSTABILITY, AND SWELLING. THE REPORT FURTHER STATES THAT THE LOOSENING OF THE FEMORAL COMPONENT WAS NOTED. FEMORAL COMPONENT HAD NO FIXATION TO THE CEMENT, BUT CEMENT HAD A GOOD FIXATION TO-THE BONE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis
MAUDE report 25217291 ↗InjuryMay 14, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED OSTEOLYSIS, POLYETHYLENE LINER WEAR AND LOOSENING OF THE FEMORAL COMPONENT. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 4 YEARS AND 8 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Osteolysis
MAUDE report 25174984 ↗InjuryMay 13, 2026Naturally Worn
AS REPORTED, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT SURGERY. APPROXIMATELY 11 MONTHS LATER, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO A LOOSE FEMUR. BECAUSE THE PATIENT HAS FILED A SHORT FORM, IT APPEARS THAT THEY ARE ALLEGING PROSTHESIS WEAR OF AN EXACTECH POLYETHYLENE DEVICE.
Patient problems: Pain
MAUDE report 25159617 ↗InjuryMay 12, 2026Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY AND OPERATIVE NOTES, THE PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT SURGERY. THE PATIENT HAD INITIALLY DONE WELL BUT STARTED HAVING INCREASED PAIN AND SWELLING. AN INFECTION WORKUP WAS NEGATIVE. APPROXIMATELY 4 YEARS AND 4 MONTHS POST THE INITIAL SURGERY; THE PATIENT¿S RIGHT KNEE WAS REVISED TO NON-EXACTECH COMPONENTS DUE TO SUSPECTED POLYETHYLENE WEAR AND FEMORAL COMPONENT LOOSENING. PER THE OPERATIVE NOTES, THERE WAS A TYPICAL SYNOVITIS WITH PARTICULATE DEBRIS AND THE SYNOVIAL TISSUE IN THE MEDIAL AND LATERAL GUTTERS. THERE WAS BROWNISH DISCOLORATION AS WELL AND LOOKED GRITTY. SURGEON DEBRIDED THIS SYNOVIAL TISSUE AND SENT A SAMPLE OF THE TISSUE FOR CULTURE. THERE WERE NO SIGNS OF PURULENCE OR INFECTION. ON GROSS INSPECTION, THERE WAS NO SIGNIFICANT WEAR (TO THE TIBIAL INSERT). THERE WERE SOME PITTING CHANGES IN THE ARTICULAR SURFACE, PRIMARILY MEDIALLY AND THE FEMORAL COMPONENT WAS DISIMPACTED WITHOUT ANY DIFFICULTIES AS THERE WAS NO ATTACHMENT TO THE CEMENT MANTLE. ADDITIONALLY, THERE WAS GROSS DAMAGE TO THE PATELLAR BUTTON. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CO
Patient problems: Aseptic loosening; Pain; Swelling/ Edema; Synovitis
MAUDE report 25150239 ↗InjuryMay 7, 2026Naturally Worn
AS REPORTED BY LEGAL NOTIFICATION, APPROXIMATELY 1 YEAR AND 8 MONTHS POST THE INITIAL TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED. BECAUSE THE PATIENT HAS FILED A LEGAL CLAIM, IT APPEARS THAT THEY ARE ALLEGING PROSTHESIS WEAR OF THEIR EXACTECH DEVICE.
Patient problems: Insufficient Information
MAUDE report 25111874 ↗InjuryApr 29, 2026Naturally Worn
REPORT #3 OF 3 FOR THIS EVENT. IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, A FEW WEEKS LATER, THE PATIENT EXPERIENCED PAIN. ONE (1) YEAR, FIVE (5) MONTHS LATER, THE PATIENT REPORTS PAIN AND DISSATISFACTION WITH IMPLANT FUNCTION. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE DUE TO LOOSE TIBIA. IT WAS NOTED THE TIBIA WAS LOOSE WITH ONLY FIBROUS INGROWTH AND THE FEMUR HAD MINIMAL BONE INGROWTH. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. ADDITIONALLY, IT WAS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAS SUFFERED SEVERE PAIN AND LOSS OF MOBILITY DUE TO PROSTHESIS WEAR. NO ADDITIONAL INFORMATION IS AVAILABLE. 510K; K171045 CONCOMITANT PRODUCTS: - TRULIANT PS POR FEM PS POR RIGHT SZ 4.5(CAT#02-020-12-0345/SERIAL# 5758187) - TRULIANT TIB IMP PS INSERT SZ 4.5 9MM(CAT#02-022-35-4509/SERIAL# 5316760) - ADVANCED PATELLA 32MM 3 PEG IMPLANT(CAT#200-07-32/SERIAL# 6857967)
Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Pain
MAUDE report 25027585 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN WITH EFFUSION AND HAD A RIGHT KNEE ASPIRATION APPROXIMATELY EIGHT MONTHS POST-SURGERY. APPROXIMATELY FIVE YEARS AND NINE MONTHS LATER, THE PATIENT UNDERWENT A REVISION DUE TO FAILED POLYETHYLENE. DESPITE UNDERGOING THE REVISION SURGERY, THE PATIENT EXPERIENCES DAILY PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; THAT LIMITS THEIR ACTIVITIES OF DAILY LIVING. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Osteolysis; Pain; Unspecified Tissue Injury
MAUDE report 24912991 ↗InjuryApr 10, 2026Naturally Worn
IT WAS REPORTED THAT A 60YEAR OLD MALE PATIENT, WHO WAS HAD AN INITIAL LEFT KNEE REPLACEMENT ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 4 YEARS 5 MONTHS POST THE INITIAL IMPLANT PROCEDURE. THE SURGEON REVISED A SIZE 3 LEFT FEMUR WHICH WAS LOOSE AND PS SIZE 3/9MM INSERT TO A LEFT SIZE 3 CONSTRAINED CONDYLAR FEMUR WITH A 14X120 STEM AND A CONSTRAINED SIZE 3/9MM INSERT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WERE NOT ABLE TO BE OBTAINED BY THE REP FOR RETURN.
Patient problems: Discomfort; Muscle Weakness/Atrophy; Pain
MAUDE report 24839501 ↗InjuryApr 8, 2026Unstable
IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RTKA, UNDERWENT A REVISION PROCEDURE DUE TO INSTABILITY. THE 12MM POLY WAS FOR A 15MM INSERT. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO HOSPITAL POLICY. NO IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.
Patient problems: Joint Dislocation
MAUDE report 24822909 ↗
Other Exactech, Inc. products
- Equinoxe305 models · 2,076 reports · 37 recalls
- Optetrak Logic408 models · 3,306 reports · 3 recalls
- Novation184 models · 1,145 reports · 25 recalls
- Optetrak336 models · 1,773 reports · 6 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.
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