Optetrak 204-24-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10885862048387), received between Oct 12, 2020 and Apr 20, 2026 — classified as 38 injuries.

The most frequently reported specific device problem is “Naturally Worn” (31 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (K933610); 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. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0019-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Naturally Worn

  IT WAS REPORTED THAT A PATIENT, WHO HAD A RIGHT TKA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 11 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE TIBIAL AND PATELLAR POLYS WERE REVISED DUE TO WEAR. SIGNIFICANT WEAR WAS FOUND ON THE TIBIAL INSERT (POSTERIORLY AND MEDIAL CONDYLE) AND THE PATELLA POLY. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS 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 AS THEY WERE DISCARDED. NO IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24933842 ↗
• InjuryDec 26, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 125 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, AMBULATION DIFFICULTIES, FAILURE OF IMPLANT. JOINT LAXITY, PAIN, OSTEOLYSIS, AND SWELLING/EDEMA.. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21020707 ↗
• InjurySep 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 144 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20268508 ↗
• InjurySep 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY UNKNOWN MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, EFFSION, INSTABILITY, SYNOVITIS AND OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 20129747 ↗
• InjurySep 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 107 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, OSTEOLYSIS, PAIN, DISCOMFORT, GAIT, POOR BALANCE, DIFFICULTY WALKING, METALLOSIS,EMOTIONAL DISTRESS AND PAIN AND SUFFERING. 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; Balance Problems; Discomfort; Emotional Changes; Osteolysis; Pain

  MAUDE report 20126185 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 142 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SUFFERING, TROUBLE WALKING/STANDING, NEED FOR ADDITIONAL SURGERY AND THERAPIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20034552 ↗
• InjuryJul 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 69 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN (B)(6) 2012, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 12 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POLY WEAR AND MASSIVE OSTEOLYSIS. EVERYTHING WAS REMOVED AND EXCHANGED TO A COMPETITOR¿S KNEE. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS 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 ANALYSIS AS THEY WERE DISCARDED BY THE CUSTOMER. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Osteolysis

  MAUDE report 19833866 ↗
• InjuryJul 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 161 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, INTERMITTENT PAIN, UNABLE TO WALK LONG DISTANCES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Pain

  MAUDE report 19756852 ↗
• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 200 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE FUTURE REVISION SURGERY DUE TO PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643518 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS 82 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 17 YEARS POST OP. THE PATIENT WAS REVISED DUE TO INFECTION. PATIENT WAS REVISED TO SAME SIZE PS TIBIAL INSERT SZ 4 9MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PRODUCT NOT RETURNING - HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 19555013 ↗
• InjuryMay 24, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 115 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, ASEPTIC LOOSENING, KNEE PAIN, SWELLING, JOINT EFFUSION, BONE LOSS, DIFFICULTY WALKING, AND LIMITED RANGE OF MOTION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Emotional Changes; Joint effusion; Loss of Range of Motion; Osteolysis

  MAUDE report 19392095 ↗
• InjuryMay 23, 2024Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, TIGHTNESS, A "PINCHING SENSATION", A "PULLING SENSATION", INFECTION, INSTABILITY, LIMITED RANGE OF MOTION, AND LOSS OF MOBILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint Laxity; Loss of Range of Motion; Unspecified Infection

  MAUDE report 19383994 ↗
• InjuryMay 20, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 83 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS TIBIAL LOOSENING, TOTAL KNEE ARTHROPLASTY FAILURE DUE TO CYSTIC CHANGE, AND ARTHRITIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Cyst(s); Failure of Implant; Scar Tissue

  MAUDE report 19350695 ↗
• InjuryApr 23, 2024Fracture; Detachment of Device or Device Component; Naturally Worn; Fracture; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE PROCEDURE ON (B)(6) 2012 AND THEN IT WAS REVISED ON (B)(6) 2019. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, POLYETHYLENE WEAR, OSTEOLYSIS, SYNOVITIS, FRACTURE OF THE TIBIAL COMPONENT, FAILURE OF THE POLYETHYLENE INSERT LOCKING MECHANISM.

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

  MAUDE report 19165130 ↗
• InjuryMar 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2018 APPROXIMATELY 4 YEARS 8 MONTHS AFTER INITIAL IMPLANT. THERE IS NO DEVICE INFORMATION PROVIDED. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18958380 ↗
• InjuryMar 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2008, WITH NO REPORTED REVISION. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 18853955 ↗
• InjuryMar 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2008, WITH NO REPORTED REVISION. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18853873 ↗
• InjuryFeb 20, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 13 YEARS POST INITIAL LEFT TKA, THE 73 Y/O MALE PATIENT WAS REVISED DUE TO POLY ISSUES WITH FLAKING AND DELAMINATION. THE PATELLA WAS WORN IN HALF. THE PATIENT EXPERIENCED OSTEOLYSIS ISSUE DUE TO POLY WEAR. THE PATIENT WAS REVISED TO A SIZE 4 CC FEMORAL COMPONENT. THE PATELLA WAS REVISED TO A 38MM. THE LINER WAS REVISED TO A PSC SIZE 4, 11MM. THE FEM AUGMENTS WERE ALSO REQUIRED DUE TO LACK OF BONE. THERE WAS A GREATER THAN 45 MINUTE SURGICAL DELAY/PROLONGATION DUE TO THE EVENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 18739883 ↗
• InjuryNov 15, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2008. APPROXIMATELY 15 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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 ON (B)(6) 2023 DIAGNOSIS: PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC RIGHT KNEE JOINT NOTABLY, THERE WAS SEVERE REACTIVE SYNOVITIS AND JOINT EFFUSION CONSISTENT WITH POLYETHYLENE WEAR. A TOTAL SYNOVECTOMY WAS PERFORMED. THE TIBIAL INSERT WAS REMOVED WHICH WAS FOUND TO HAVE SIGNIFICANT MEDIAL SIDED WEAR. ON INSPECTION, THE FEMORAL COMPONENT WAS WELL FIXED WITH ONLY A SMALL AMOUNT OF OSTEOLYSIS ON THE POSTEROLATERAL CONDYLE. THE TIBIAL COMPONENT WAS ALSO WELL-FIXED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint effusion; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 18142274 ↗
• InjuryNov 3, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6) 2009. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 13 YEARS 6 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT POSTOPERATIVE DISGNOSIS: FAILED RIGHT TOTAL KNEE ARTHROPLASTY DUE TO MECHANICAL LOOSENING AND CATASTROPHIC POLYETHYLENE WEAR RESULTING IN SEVERE OSTEOLYSIS. THE PATIENT TOLERATED THE PROCEDURE WELL, WAS AWOKEN AND WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. HERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 18065968 ↗
• InjuryAug 1, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY TEN YEARS POST INITIAL RIGHT TKA, THE 70 Y/O MALE PATIENT HAD A REVISION DUE TO LOOSE PATELLA, POLY ISSUES AND OSTEOLYSIS OF THE TIBIA. SURGEON CHANGED THE LINER, PATELLA AND TIBIAL TRAY AND ALSO USED AN EXTENSION STEM. THERE WERE NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND PHOTOS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED BY THE HOSPITAL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Osteolysis

  MAUDE report 17434080 ↗
• InjuryJun 6, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A BILATERAL KNEE REPLACEMENT ON (B)(6) 2006. APPROXIMATELY 16 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022 DUE TO EXTENSIVE OSTEOLYSIS WITH RECURRENT LARGE EFFUSIONS AND ASEPTIC LOOSENING. 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 (B)(6) 2022 FINDINGS: LARGE CLEAR YELLOW JOINT EFFUSION. EXTENSIVE SYNOVITIS. NO EVIDENCE OF INFECTION. GROSSLY LOOSE PATELLA AND FEMORAL COMPONENTS. WELL FIXED TIBIAL COMPONENT. EXTENSIVE OSTEOLYSIS OF FEMUR, PATELLA AND TIBIA. AORI TYPE 3 BONE LOSS FEMUR, AORI TYPE IIA MEDIAL BONE LOSS TIBIA. VARUS ALIGNMENT WITH GROSS INSTABILITY UNDER ANESTHESIA. SEVERE POLYETHYLENE WEAR. THERE WERE NO COMPLICATIONS. A SURGICAL DEBRIEF WAS PERFORMED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 17069588 ↗
• InjuryMay 30, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY TEN YEARS POST INITIAL LEFT TKA, THE 68 Y/O MALE PATIENT HAD A REVISION DUE TO POLY ISSUES WITH FLAKING AND DELAMINATION. PATIENT HAD MASSIVE OSTEOLYSIS ISSUE DUE TO POLY WEAR. EVERYTHING WAS REMOVED. THERE WERE PARTS OR PIECES OF THE DEVICE THAT FELL INTO PATIENT WOUND SITE AND WERE REMOVED BY SURGEON. THERE WAS A GREATER THAN 45 MINS SURGERY DELAY/PROLONGATION. PATIENT REVISED TO COMPETITOR'S DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE HOSPITAL REFUSED TO PROPERLY CLEAN THE PROSTHESIS, THERE WAS BONE AND BLOOD STILL ON THE COMPONENTS. THE EXPLANTS WERE DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 17025982 ↗
• InjuryApr 21, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  PER A REPORT FROM THE LEGAL DEPARTMENT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE REPLACEMENT (B)(6) 2006. APPROXIMATELY 9 YEARS AND 8 MONTHS AFTER THE INITIAL SURGERY THE PATIENT HAD THEIR FIRST LEFT KNEE REVISION ON (B)(6) 2015. THE PATIENT THEN UNDERWENT ANOTHER LEFT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 6 YEARS AND 10 MONTHS AFTER THE FIRST REVISION PROCEDURE DUE TO ACCELERATED AND PREVENTABLE WEAR. 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; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 16784959 ↗
• InjuryApr 14, 2023Naturally Worn; Naturally Worn

  LEGAL CASE - (B)(6). IT WAS REPORTED BY THE LEGAL DEPARTMENT THE PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2006. THE PATIENT HAD A LEFT KNEE REVISION (B)(6) 2022, APPROXIMATELY 16 YEARS AND 4 MONTHS AFTER INITIAL REPLACEMENT. LEFT KNEE WAS REVISED DUE TO OSTEOLYSIS DUE TO POLYETHYLENE WEAR STATUS POST RECALLED EXACTECH TOTAL KNEE REPLACEMENT, ASEPTIC LOOSENING. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. SERIAL #: (B)(4), CATEGORY #: 204-24-09 - PS TIBIAL INSERTS SZ 4, 9MM, SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K933610. RECALL: Z-0021-2022. NO EBI RESULTS.

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

  MAUDE report 16742283 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933610. 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-2155-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
• Z-0582-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-
• Z-2070-2012 · Sep 23, 2011 · Terminated
  Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 2
• Z-0347-05 · Nov 11, 2004 · Terminated
  Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.