Optetrak 200-02-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 10885862039590), received between Nov 25, 2019 and Aug 18, 2026 — classified as 121 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (93 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 other recalls cover devices cleared under the same FDA submission (K932690); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 18, 2024Class IIOpen, Classified

   Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

   Z-2155-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Nov 21, 2023Class IIOpen, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0582-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Naturally Worn

  It was reported that this patient underwent a right knee replacement. Subsequently, the tibial insert and patellar polyethylene components were revised due to wear. The patellar polyethylene demonstrated significant wear with mild associated osteolysis; however, no bone grafting was required. The tibial insert also demonstrated moderate wear. The patient was last known to be in stable condition following the event. No further information is available.

  Patient problems: Osteolysis

  MAUDE report 50305571 ↗
• InjuryAug 11, 2026Naturally Worn

  It was reported patient had an initial left total knee arthroplasty. Subsequently, eleven (11) years nine (9) months later, the patient was revised due to polyethylene flaking and delamination. The patella and tibial insert components were replaced. Patient was last known to be in stable condition following the event.(b)(6) 204-24-09 Tibial Insert Posterior Stabilized SZ 4, 9mm ***Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that DOES NOT contain EVOH. 510k: K933610 UDI:(b)(4). CONCOMITANTS: 2025330 204-04-45 Tibial tray trapezoid, cemented. 2232579 234-02-04 Asymmetric femoral posterior stabilized, cemented SZ 4 LEFT. 2228270 200-02-32 3 Peg Patella, cemented 32mm.

  Patient problems: Insufficient Information

  MAUDE report 50212473 ↗
• InjuryJul 7, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED LAXITY, EFFUSION, PAIN, AMBULATION DIFFICULTIES AND SYNOVITIS. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 8 YEARS AND 6 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Joint Laxity; Joint effusion; Pain; Synovitis

  MAUDE report 25733278 ↗
• InjuryJul 6, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REPORT #3 OF 4 FOR THIS EVENT. IT WAS REPORTED A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, SWELLING AND INSTABILITY. AS A RESULT, EIGHT (8), YEARS, FIVE (5) MONTHS LATER, THE PATIENT UNDERWENT A REVISION PROCEDURE. A REVISION OPERATIVE REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS WAS NOTED AS ASEPTIC LOOSENING, RIGHT TOTAL KNEE ARTHROPLASTY. INTRAOPERATIVELY, IT WAS NOTED THE FEMORAL, TIBIAL AND PATELLA COMPONENTS WERE SIGNIFICANTLY LOOSE. SYNOVITIS WAS EVIDENT. THE PATIENT WAS TRANSFERRED TO PATIENT AFTER CARE UNIT IN STABLE CONDITION. ADDITIONALLY, IT WAS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAS EXPERIENCED AND CONTINUES TO EXPERIENCE PAIN, 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; Aseptic loosening; Discomfort; Erosion; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 25717963 ↗
• InjuryMay 7, 2026Naturally Worn

  AS REPORTED, THIS PATIENT¿S POLY WAS EXCHANGED DUE TO WEAR. PATIENT¿S KNEE WAS INFECTED, AND A POLY AND PATELLA REVISION WAS PERFORMED DUE TO THE POROUS NATURE OF THE MATERIAL. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED BY THE HOSPITAL. PER SALES REP. ¿KINDLY NOTE WE HAVE NO RECORDS OF THE INDEX SURGERY DATE OR THE SERIAL NUMBERS OF WHAT THE PATIENT HAD¿ NO ADDITIONAL INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 25111649 ↗
• InjuryMay 7, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS AND 10 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT'S TIBIAL AND PATELLAR POLYS WERE REVISED DUE TO WEAR. THE PATELLA POLY SHOWED MORE SIGNIFICANT WEAR, WITH MILD OSTEOLYSIS OF THE BONE. NO BONE GRAFT REQUIRED. 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 25110945 ↗
• InjuryApr 21, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS AND 7 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT'S TIBIAL AND PATELLAR POLYS WERE REVISED DUE TO WEAR. BONE SCANS SHOWED HOT ACTIVITY ON THE POSTERIOR FEMUR, WHICH COULD INDICATE OSTEOLYSIS AND LOOSENING OF THE COMPONENT. INTRA-OP FINDINGS DEMONSTRATED A WELL-FIXED FEMUR, THEREFORE ONLY THE POLYS WERE REVISED. 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 24944231 ↗
• InjuryApr 7, 2026Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL NOTIFICATION, APPROXIMATELY 10 YEARS AND 8 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND OSTEOLYSIS. THE OPERATIVE REPORTED NOTED THAT THERE WAS WEAR OF THE POLYETHYLENE LINER, AND THERE WAS NO EVIDENCE OF INFECTION. POSTERIOR SYNOVITIS, SCAR TISSUE AND OSTEOPHYTES WERE REMOVED. THE PATELLA WAS NOTED TO BE WELL FIXED, BUT THERE WAS SOME WEAR. PER THE AVAILABLE INFORMATION, THE PATIENT ALLEGES THEY HAVE SUFFERED AND CONTINUE TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES WHICH ALL REQUIRE ONGOING MEDICAL CARE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Cyst(s); Joint Laxity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 24798856 ↗
• InjuryApr 6, 2026Naturally Worn

  AS REPORTED, A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED INSTABILITY AND SCANS SUGGESTED POLY WEAR. INTRA-OP FINDINGS SHOWED WEAR ON THE TIBIAL AND PATELLAR POLYS. THE DECISION WAS MADE TO REVISE THE TIBIA AND PATELLAR COMPONENTS. ALL OTHER PROSTHESIS WERE CONSIDERED TO BE WELL-FIXED. 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: Joint Laxity

  MAUDE report 24788743 ↗
• InjuryApr 3, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED TIBIAL AND PATELLAR POLYETHYLENE WEAR. FEMORAL LOOSENING, OSTEOLYSIS AND SYNOVITIS. AS A RESULT, APPROXIMATELY FOUR YEARS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PATIENT CONTINUES TO BE LIMITED IN HIS ACTIVITIES OF DAILY LIVING, FOLLOWING THE REVISION SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Osteolysis; Pain; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 24780653 ↗
• InjuryJan 28, 2026Naturally Worn

  REPORT #2 OF 2 FOR THIS EVENT: AS REPORTED, APPROXIMATELY TWO (2) YEARS POST AN INITIAL LEFT TOTAL LEFT KNEE ARTHROPLASTY, THIS PATIENT WAS REVISED DUE TO POLY WEAR. THE PATELLA AND TIBIAL INSERT COMPONENTS WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24202077 ↗
• InjuryDec 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA (TOTAL KNEE ARTHROPLASTY) ON THE RIGHT SIDE. SUBSEQUENTLY, THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. THERE WAS MILD OSTEOLYSIS PRESENT AND THE PATELLA EXHIBITED SIGNIFICANT WEAR ALONG LATERAL TRACKING PATH. THE TIBIAL INSERT ALSO HAD MINIMAL WEAR ON MEDIAL AND LATERAL ARTICULAR SURFACE. FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. AS A RESULT, THE TIBIAL AND FEMORAL COMPONENTS WERE RETAINED WHILE THE PATELLA AND TIBIAL INSERT COMPONENTS WERE REPLACED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Osteolysis

  MAUDE report 23830217 ↗
• InjuryOct 16, 2025Naturally Worn; Naturally Worn

  AS REPORTED, A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR WEAR OF THE PATELLA AND POLY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23309026 ↗
• InjurySep 8, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED RADIOLUCENT OSTEOLYSIS AND PAIN. AS A RESULT, APPROXIMATELY FOUR YEARS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2 FOR THIS EVENT/PATIENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 22998675 ↗
• InjurySep 8, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST INITIAL LEFT TKA, THE MALE PATIENT HAD AN ORIGINAL EXACTECH TKA DONE. THE PATIENT RETURNED TO SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT UNDERWENT A POLY INSERT AND PATELLA IMPLANT SWAP. PATIENT WAS REVISED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE IMPLANT(S) IS SENT TO THE LAB AND LEGAL AT THE HOSPITAL. IMAGES, X-RAYS, EBI ATTACHED. NO FURTHER MEDICAL/PATIENT INFORMATION PROVIDED.

  Patient problems: Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 22991716 ↗
• InjuryAug 19, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT RETURNED TO THE SURGEONS OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TOTAL KNEE ARTHROPLASTY. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION FOR POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT UNDERWENT A POLY TIBIAL INSERT SWAP AND PATELLA IMPLANT SWAP. THERE WAS WHITE SYNOVITIS BUT NO GROSS PURULENCE OR INFLAMED SYNOVITIS. CULTURES WERE OBTAINED ON INITIALLY ENTERING THE JOINT. THE POLYETHYLENE INSERT WAS REMOVED. THIS DID SHOW SIGNIFICANT WEAR AND OXIDATION CENTRALLY AS WELL AS MEDIALLY AND LATERALLY. THERE WAS NO GROSS FRACTURE OR MECHANICAL FAILURE OF THE POLYETHYLENE. THE PCL WAS RESECTED IN ITS ENTIRETY. ATTENTION THEN TURNED TOWARDS EVALUATION OF THE FEMORAL COMPONENT. THERE WAS NO SUBSTANTIAL OSTEOLYSIS NOTED AROUND THE FEMORAL COMPONENT. IT WAS WELL FIXED DESPITE VIGOROUS IMPACTION. ATTENTION WAS THEN TURNED TOWARDS THE TIBIA. THERE WAS NO SIGNIFICANT AREA OF OSTEOLYSIS CONSISTENT WITH PREOPERATIVE CT INVOLVING THE MEDIAL ASPECT OF THE COMPONENT. THIS WAS ABOUT 1CM IN PROXIMAL DISTAL

  Patient problems: Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 22840066 ↗
• InjuryJul 31, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED APPROXIMATELY 57 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT SURGERY, THE PATIENT EXPERIENCED PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION AND SUBSEQUENTLY UNDERWENT A LEFT REVISION PROCEDURE. REVISION OPERATIVE REPORT WAS PROVIDED. INTRAOPERATIVELY, EFFUSION AND SYNOVITIS WERE APPRECIATED AROUND THE JOINT CONSISTENT WITH POLYETHYLENE WEAR. THE PATELLA COMPONENT WAS NOTED TO HAVE WEAR CENTRALLY. THE INSERT AND PATELLA WERE REVISED. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED AND RETAINED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Joint Laxity; Joint effusion; Muscle/Tendon Damage; Swelling/ Edema; Synovitis

  MAUDE report 22676558 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 103 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS RIGHT KNEE PAIN AND A LARGE LATERAL OSTEOPHYTE ON PATELLA. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED RIGHT KNEE PAIN FOLLOWING TOTAL KNEE ARTHROPLASTY. THE SURGEON NOTED THAT MOST OF HER SYMPTOMS WERE LIKELY RELATED TO THE LARGE PATELLAR OSTEOPHYTE AND LATERAL TILT, ALTHOUGH HER POLYETHYLENE WAS SUBJECT TO RECALL. FINDINGS INDICATED HER METALLIC COMPONENTS APPEARED TO BE WELL FIXED. SHE HAD NO APPRECIABLE WEAR ON THE POLYETHYLENE INSERT, AND IT WAS REPLACED WITH THE SAME THICKNESS CRC INSERT. THE LARGE LATERAL OSTEOPHYTE WAS REMOVED WITH ELECTROCAUTERY AND A MICRO-OSCILLATING SAW. THE SURGEON PERFORMED A SLIGHT LATERAL RELEASE TO IMPROVE HER TILT. THE PATIENT WAS AWAKENED AND TAKEN TO RECOVERY IN SATISFACTORY CONDITION. THERE WERE NO IMMEDIATE COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain

  MAUDE report 22211623 ↗
• InjuryJun 4, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6.5 YEARS POST OP INITIAL LEFT TKA, THIS PATIENT WAS REVISED DUE TO POLY DELAMINATION AND PATELLA/POLY WEAR. THE PATIENT WAS REVISED TO A SIZE 3, 11MM TIBIAL INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22140502 ↗
• InjuryJun 2, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS AND 3 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION. THE PATIENT WAS REVISED. THE OP REPORT NOTED THERE WAS EVIDENCE OF MILD-TO-MODERATE WEAR INVOLVING THE POSTERIOR MEDIAL ASPECT OF THE POLYETHYLENE IN PARTICULAR. DESPITE VIGOROUS IMPACTION, THE FEMORAL AND TIBIAL COMPONENTS WERE STABLE, THOUGH THERE WAS EVIDENCE OF SOME LYSIS INVOLVING THE MEDIAL ASPECT OF THE TIBIA. 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: Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 22125568 ↗
• InjuryMay 28, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THE PATIENT HAD A LEFT KNEE REPLACEMENT. APPROXIMATELY 8 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE, THE PATIENT HAD A LEFT KNEE REVISION. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: DAILY PAIN AND DISCOMFORT. 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. REVISION OP REPORT DIAGNOSIS: DEGENERATIVE JOINT DISEASE, LEFT KNEE, STATUS POST TOTAL KNEE ARTHROPLASTY WITH LARGE CYST AND WEAR OF POLY. KNEECAP WAS EVERTED AND MARKED FLUID WAS EXPRESSED. AT THIS POINT, EXTENSIVE DEBRIDEMENT WAS DONE. CULTURES WERE OBTAINED. TISSUE WAS SENT TO PATHOLOGY, WHICH SHOWED NO ACUTE INFLAMMATION. AFTER APPROPRIATE RELEASES, THE POLY WAS EXPOSED AND THE OLD POLY WAS REMOVED. THIS CYST WAS EXCISED CIRCUMFERENTIALLY AND A LARGE FLUID SAC WAS REMOVED. AGAIN, CULTURES AND TISSUE HAVE BEEN OBTAINED. WE BEGAN EVALUATING THE JOINT, THE POLY SHOWED WEAR ON THE PATELLA. IT WAS MILD TO MODERATE IN NATURE. THE FEMUR AND TIBIA WERE COMPLETELY INTACT WITH NO EVIDENCE OF LOOSENING. THE PATIENT WAS AWAKENED

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Cyst(s); Discomfort; Implant Pain; Swelling/ Edema

  MAUDE report 22095278 ↗
• InjuryMay 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED APPROXIMATELY 84 MONTHS AFTER RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT EXPERIENCED PAIN AND SUBSEQUENTLY UNDERWENT A RIGHT KNEE REVISION PROCEDURE OF THE INSERT, PATELLA AND TRAY COMPONENTS. NO MEDICAL RECORDS, PICTURES OR X-RAYS WERE PROVIDED. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22092248 ↗
• InjuryMay 22, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6.5 YEARS POST INITIAL LEFT TKA, THE PATIENT WAS REVISED DUE TO LOOSENING, OSTEOLYSIS AND POLY WEAR. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED AT HOSPITAL.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 22070110 ↗
• InjuryMay 13, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED APPROXIMATELY 175 MONTHS POST A RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT PRESENTED WITH PAIN AND APPROXIMATELY A WEEK LATER UNDERWENT SCHEDULED A SECOND RIGHT KNEE REVISION PROCEDURE OF THE FEMORAL COMPONENT INSERT AND PATELLA COMPONENTS. IT WAS NOTED THE INSERT AND PATELLA WERE REPLACED DUE TO RECALLS AND THE FEMORAL COMPONENT WAS SIGNIFICANTLY LOOSE. PICTURES OF THE EXPLANTS WERE PROVIDED. THERE WERE NO SURGICAL DELAYS OR MEDICAL INTERVENTIONS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22009632 ↗
• InjuryMay 6, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 13 YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO POLY WEAR. THE POLY WAS SWAPPED OUT FOR A 15MM PS INSERT. THE PATELLA WAS REVISED TO A COMPETITOR'S PATELLA. PHOTOS PROVIDED SHOW WEAR OF THE PATELLA. THE POLY DEBRIS FROM THE INSERT AND PATELLA WAS REMOVED AND WASHED OUT. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21967685 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932690. One submission often covers many models, so check the product and lot details in each record.

• Z-2157-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
• Z-2156-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
• Z-2158-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
• Z-0019-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-1