Optetrak 200-02-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10885862039620), received between Aug 4, 2022 and Apr 3, 2026 — classified as 33 injuries.

The most frequently reported specific device problem is “Naturally Worn” (27 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 16, 2026.

Recalls naming this device

1. Apr 18, 2024Open, 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, 2023Open, 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED FEMORAL LOOSENING SECONDARY TO TIBIAL AND PATELLA POLYETHYLENE WEAR. AS A RESULT, APPROXIMATELY FOUR YEARS EIGHT MONTHS 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. THIS IS REPORT 3 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Aseptic loosening

  MAUDE report 24779435 ↗
• InjuryFeb 18, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND A LOOSE FEMUR. AS A RESULT, THEY WERE REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 24376865 ↗
• InjuryDec 30, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THIS PATIENT WAS REVISED DUE TO A SWOLLEN KNEE AND PAIN DUE TO POLYETHYLENE WEAR. THE INSERT AND PATELLA COMPONENTS WERE REVISED. THE 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: Implant Pain; Swelling/ Edema

  MAUDE report 23926214 ↗
• InjuryDec 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THREE (3) YEARS LATER, THE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE DUE TO ASEPTIC LOOSENING OF THE PATELLA COMPONENT AND PROSTHESIS WEAR. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. EBI INITIAL SURGERY ATTACHED (B)(6) - 02-012-51-5009 - LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH 510K: K123342 . CONCOMITANTS:

  Patient problems: Aseptic loosening

  MAUDE report 23896445 ↗
• InjuryApr 23, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY 89 MONTHS AFTER A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REVISION PROCEDURE, THE PATIENT EXPERIENCED PAIN AND MOBILITY ISSUES. OPERATIVE PHOTOS/X-RAYS WERE PROVIDED. INTRAOPERATIVELY, THE SURGEON OBSERVED SIGNIFICANT WEAR ON BOTH THE TIBIAL INSERT AND PATELLA POLYETHYLENE COMPONENTS. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. . CONCOMITANTS PRODUCTS: COMPLAINT INVESTIGATION FINDINGS: THE REVISION REPORTED WAS LIKELY THE RESULT OF INSTABILITY, AXIAL ROTATIONAL MISMATCH BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, AND/OR PATIENT-RELATED CONDITIONS, WHICH RESULTED IN POLYETHYLENE WEAR, DELAMINATION, AND PAIN. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF "PROSTHESIS WEAR¿ IS ASSOCIATED WITH MATERIAL DAMAGE TO A SURFACE, USUALLY INVOLVING PROGRESSIVE LOSS OR DISPLACEMENT OF MATERIAL, DUE TO RELATIVE MOTION BETWEEN THAT SURFACE AND A CONTACTING SUBSTAN

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 21889773 ↗
• InjuryMar 14, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3.5 YEARS POST OP INITIAL RIGHT TKA, THIS 72 Y/O MALE PATIENT WAS REVISED. PATIENT PRESENTED WITH A SORE KNEE AFTER A FALL FROM A LADDER. AFTER OPENED THE KNEE, SURGEON FOUND POLY AND OSTEOLYSIS ISSUE. THIS SEEMS TO BE FROM THE PATELLA WEAR. LINER AND PATELLA WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS & X-RAYS ATTACHED. PRODUCT NOT RETURNING - IT WAS DISCARDED.

  Patient problems: Joint effusion; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 21606629 ↗
• InjuryMar 7, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 91 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, POSSIBLE NICKEL ALLERGY, EXTENSIVE DAMAGE TO THE POSTERIOR ASPECT OF THE POLYETHYLENE AS WELL AS TO THE POST, SOFT TISSUE CHANGES CONSISTENT WITH EXTENSIVE POLY WEAR, FRAGMENTS OF POLY FOUND IN SOFT TISSUE, POLY WEAR OF THE PATELLA BUTTON, AND A LOOSE FEMORAL COMPONENT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction; Implant Pain; Osteolysis

  MAUDE report 21552379 ↗
• InjuryFeb 18, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 142 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 21400441 ↗
• InjuryFeb 10, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 114 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, AMBULATION DIFFICULTIES, JOINT EFFUSION, JOINT LAXITY, DISCOMFORT, OSTEOLYSIS, SWELLING/EDEMA AND PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21344693 ↗
• InjuryFeb 5, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 46 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED LOOSENING, AMBULATION DIFFICULTIES, INFLAMMATION, JOINT EFFUSION, PAIN, SCAR TISSUE, AND SWELLING/EDEMA. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Joint Laxity; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 21314661 ↗
• InjuryFeb 4, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 7 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: DAILY PAIN AND DISCOMFORT IN HIS LEFT KNEE. THE PATIENT HAS SUFFERED DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT, SWELLING, GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. 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; Balance Problems; Discomfort; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21307210 ↗
• InjuryJan 24, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 64 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ASEPTIC FEMORAL COMPONENT LOOSENING AND OSTEOLYSIS. PATIENT WAS ALSO INDICATED FOR PAIN AND OSTEOARTHRITIS. DURING THE PROCEDURE IT WAS NOTED OSTEOLYTIC DEBRIS IN THE SYNOVIUM. THE PATELLA HAD SIGNIFICANT WEAR AND OXIDATION WITH OSTEOLYSIS ON THE LATERAL BORDER. TAPPING ON THE ANTERIOR FLANGE OF THE FEMORAL COMPONENT EASILY DEBONDED IT FROM THE CEMENT. A LARGE OSTEOLYTIC CONTAINED CYST IN THE LATERAL FEMORAL CONDYLE. (SEE REVISION SURGERY OPERATIVE NOTES). PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. EBI INITIAL SURGERY ATTACHED. OPERATIVE REPORT FROM REVISION SURGERY ATTACHED. NO FURTHER INFORMATION. X-RAY: NO OPERATIVE NOTES: YES.

  Patient problems: Failure of Implant; Implant Pain; Joint effusion; Osteolysis

  MAUDE report 21229638 ↗
• InjuryDec 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 89 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, AND FAILURE OF IMPLANT. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Osteolysis

  MAUDE report 20844196 ↗
• InjuryDec 2, 2024Patient-Device Incompatibility; Naturally Worn; Patient-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 15 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A PROCEDURE TO ADDRESS LATERAL PATELLAR SIDED PAIN. HE DID WELL EARLY POST OPERATIVELY AND THEN DEVELOPED PAIN, WHICH DID NOT IMPROVE OVER THE COURSE OF THE YEAR. SURGICAL WORKUP AT ONE-YEAR POST-OP REVEALED SOME TILT TO THE LATERAL PATELLA WITH A SMALL FLECK OF BONE MEDIALLY. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. INTRAOPERATIVE FINDINGS INDICATED ABUNDANT OSSEOUS OVERGROWTH ALONG THE LATERAL SIDE OF THE PATELLA. THE SURGEON PERFORMED A LEFT KNEE DEBRIDEMENT OF THE LATERAL PATELLA BONE AND A LATERAL RETINACULAR RELEASE. AT THE COMPLETION OF THE PROCEDURE THE PATELLAR WAS TRACKING WELL WITH NO BONY IMPINGEMENT ON THE FEMORAL COMPONENT RELATIVE TO THE PATELLA. THE PATIENT WAS TRANSFERRED TO THE PACU IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Exostosis (bone); Pain; Scar Tissue

  MAUDE report 20820627 ↗
• InjuryNov 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 59 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS, AND IMPLANT PAIN. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Osteolysis; Synovitis

  MAUDE report 20758312 ↗
• InjuryNov 19, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS AND 5 MONTHS POST INITIAL RIGHT TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT UNDERWENT REVISION DUE TO RECALL. THE LINER AND PATELLA WERE EXCHANGED. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20724268 ↗
• InjuryNov 15, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS AND 4 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO POLY AND PATELLA WEAR, AND FEMORAL LOOSENING. THE TIBIAL INSERT WAS REVISED TO SIZE 3.5, 11MM. THE FEMORAL COMPONENT WAS REVISED TO SIZE 3.5. 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: Insufficient Information

  MAUDE report 20701012 ↗
• InjuryNov 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 3 YEARS AND 8 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION. THE PATELLA WAS REMOVED, AND THE TIBIAL INSERT WAS REVISED TO A SIZE 5, 11MM. POLY WEAR WAS INDICATED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20679753 ↗
• InjuryNov 5, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 4 YEARS POST OP. SURGEON PERFORMED INSERT AND PATELLA EXCHANGE. PATELLA WAS CONVERTED TO COMPETITORS DEVICE. INSERT WAS REPLACED WITH EXACTECH INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; Pain

  MAUDE report 20615150 ↗
• InjuryNov 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 63 YO MALE PATIENT WHO HAD AN INITIAL RIGHT KNEE IMPLANTED IN (B)(6)2021, AND WAS REVISED IN (B)(6) 2022, UNDERWENT A SECOND REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 2 YEARS POST THE (B)(6) 2022 PROCEDURE. EVERYTHING WAS REVISED DUE TO WEAR ON PATELLA AND TIBIAL INSERT AND WAS REPLACED WITH A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS. THEY WERE DISCARDED AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. FIRST REVISION REPORTED UNDER MDR# 1038671-2022-01234.

  Patient problems: Insufficient Information

  MAUDE report 20612763 ↗
• InjurySep 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 115 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR AND ASEPTIC FEMORAL LOOSENING SECONDARY TO OSTEOLYSIS. THE PATIENT HAS HAD RECURRENT AND PERSISTENT EFFUSIONS WITH INCREASING WEIGHTBEARING PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20125949 ↗
• InjurySep 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 66 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMALTY 4 YEARS POST OP. EVERYTHING WAS REVISED DUE TO OSTEOLYSIS/LOOSENING OF FEMUR AS A RESULT OF PATELLA AND TIBIAL INSERT WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 20125148 ↗
• InjuryAug 21, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL RIGHT TKA, THIS 75 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR AND RECALLED POLY. PATIENT COMPLAINT OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint effusion; Pain; Synovitis

  MAUDE report 20015002 ↗
• InjuryJul 25, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS AND 2 MONTHS POST THE INITIAL LEFT TKA, THE PATIENT WAS REVISED DUE TO WEAR ON PATELLA AND TIBIAL INSERT, AND THE FEMORAL COMPONENT DEBONDED FROM THE CEMENT. EVERYTHING WAS REMOVED AND REPLACED WITH COMPETITOR DEVICES. 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: Insufficient Information

  MAUDE report 19826835 ↗
• InjuryJul 15, 2024Naturally Worn; Naturally Worn

  APPROXIMATELY 5 YEARS AFTER INITIAL LEFT TKA, THE PATIENT WAS REVISED DUE TO WEAR ON THE PATELLA AND TIBIAL INSERT. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19740029 ↗

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-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-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-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