Optetrak 200-02-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 10885862039606), received between Sep 10, 2021 and Sep 30, 2026 — classified as 131 injuries.

The most frequently reported specific device problem is “Naturally Worn” (109 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 131 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Naturally Worn

  Report #2 of 2 for this event.As reported, this patient had an initial right total knee arthroplasty. Subsequently, four (4) years, ten (10) months later the patient underwent a revision due to polyethylene wear. The patella and tibial insert components were revised. The patient was last known to be in stable condition following the event. No additional information is available.

  Patient problems: Insufficient Information

  MAUDE report 50947020 ↗
• InjuryAug 10, 2026Naturally Worn

  As reported, approximately 6 years and 4 months post the initial left total knee arthroplasty, the patient was revised due to wear of the tibial and patellar polys. The patella poly showed moderate wear with mild osteolysis of the bone; no bone graft required. There was minimal 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 50193804 ↗
• InjuryAug 4, 2026Fracture; Naturally 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 50127238 ↗
• 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 50113608 ↗
• InjuryJun 29, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  REPORT #2 OF 2 FOR THIS EVENT. AS REPORTED A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, SEVEN (7) YEARS, EIGHT (8) MONTHS LATER, THE PATIENT EXPERIENCED OSTEOLYSIS PAIN AND INSTABILITY WITH RECURRENT EFFUSIONS. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE. A REVISION OPERATIVE REPORT WAS PROVIDED. INTRAOPERATIVELY, GLOBAL INSTABILITY AND A LARGE EFFUSION WITHOUT GROSS INFECTION WAS OBSERVED. SYNOVITIS SHOWED CONSISTENT WITH POLYETHYLENE WEAR. IT WAS NOTED THE FEMORAL COMPONENT WAS NOT GROSSLY LOOSE HOWEVER DEBONDED FROM THE CEMENT MANTLE. THE TIBIA WAS WELL FIXED. THERE WAS SIGNIFICANT OSTEOLYSIS AT THE TIBIA WITH UNCONTAINED DEFECT, AND BONE LOSS OF THE TIBIA AND FEMUR. THE PATELLA COMPONENT WAS FOUND TO BE LOOSE WITH UNDERMINING OSTEOLYSIS. THE PATIENT WAS REVISED TO ANOTHER MANUFACTURER'S CONSTRUCT. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ADDITIONALLY, IT WAS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT EXPERIENCED AND/OR CONTINUES TO EXPERIENCE SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE AND BONE LOSS. NO ADDITIONAL INFORMATION I

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 25652368 ↗
• InjuryMay 11, 2026Naturally Worn

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, AND STIFFNESS OF THEIR KNEE. THE PATIENT HAD PREVIOUSLY BEEN SEEN AND TREATED FOR A POPLITEAL CYST AND/OR BAKER'S CYST WITHIN THE KNEE. THE PATIENT HAS HAD THE CYST ASPIRATED/DECOMPRESSED IN THE OFFICE PREVIOUSLY. THE PATIENT STILL PRESENTED WITH THEIR ORIGINAL COMPLAINTS AFTER TREATMENT OF THE CYST. AN EXAMINATION WAS DONE AND X-RAYS WERE PERFORMED AND REVIEWED. THE ORIGINAL POLY IMPLANT WAS SEARCHED IN THE RECALL DATABASE AND RETURNED AS AN AFFECTED POLY IN THE RECALL. THE PATIENT WAS SCHEDULED FOR A RIGHT KNEE REVISION POSSIBLE POLY SWAP. THE PATIENT WAS REVISED APPROXIMATELY 9 YEARS AND 8 MONTHS POST THE INITIAL TOTAL KNEE ARTHROPLASTY. THE SURGEON OPENED THE KNEE JOINT, PERFORMED A SYNOVECTOMY, AND REMOVED SCAR TISSUE. THERE WAS MINIMAL INFLAMMATION WITHIN THE TISSUES AROUND THE IMPLANTS. THE SURGEON THEN EXAMINED THE IMPLANTS. AN OSTEOTOME WAS USED TO REMOVE THE ORIGINAL POLY IMPLANT. THE ORIGINAL IMPLANT SHOWED TO BE WORN POSTERIORLY AND SHOWED PITTING AND DELAMINATION ON THE SURFACE. THE POLY REMNANTS WER

  Patient problems: Cyst(s); Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 25138137 ↗
• InjuryApr 21, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PROSTHESIS WEAR. AS A RESULT, THE PATIENT UNDERWENT A REVISION AND UNKNOWN AMOUNT OF TIME POST INITIAL IMPLANT. 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 2 OF 2 FOR THIS EVENT/PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24939525 ↗
• 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 24933862 ↗
• InjuryApr 20, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS AND COMPONENT LOOSENING. AS A RESULT, APPROXIMATELY NINE YEARS AND SIX MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. IT WAS NOTED THAT THERE WAS SIGNIFICANT REACTIVE TISSUE ABOUT BOTH THE FEMORAL AND TIBIAL COMPONENTS, THEY WERE GROSSLY LOOSE, THERE WAS GROSS FRACTURE OF THE POLYETHYLENE. THE PATELLAR BUTTON HAD MINIMAL ABRASIVE WEAR. THERE WAS A LOT OF OSTEOLYTIC DEBRIS PRESENT THROUGHOUT THE KNEE. 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 2 OF 4 FOR THIS EVENT/PATIENT.

  Patient problems: Discomfort; Joint effusion; Osteolysis; Pain

  MAUDE report 24927037 ↗
• InjuryApr 14, 2026Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT, WHO HAD A TKA, UNDERWENT A REVISION PROCEDURE, APPROXIMATELY 3 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS SUFFERING FROM PATELLAR COMPONENT LOOSENING & POLYETHYLENE WEAR¿INDUCED SYNOVITIS. A SYNOVECTOMY WAS PERFORMED. THE PATELLA & TIBIAL INSERT WERE EXCHANGED. NO X-RAYS OR IMAGING WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Synovitis

  MAUDE report 24880236 ↗
• InjuryDec 29, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 9 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT PREVIOUSLY RECEIVED DIRECT IMPACT TRAUMA TO THE AFFECTED KNEE, WHICH MAY HAVE AFFECTED PATELLA TRACKING. THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MINIMAL OSTEOLYSIS WAS PRESENT. THE SURGEON REMOVED ALL OSTEOLYTIC TISSUE. THE PATELLA SHOWED MILD WEAR ALONG THE LATERAL TRACKING PATH. THE TIBIAL INSERT HAD MINIMAL WEAR. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. THE TIBIAL AND FEMORAL COMPONENTS WERE RETAINED WHILE THE PATELLA AND TIBIAL INSERT COMPONENTS WERE REPLACED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 23905945 ↗
• InjuryOct 15, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN SIDE ON AN UNKNOWN DATE. SUBSEQUENTLY, ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REVISION OF THE PATELLA COMPONENT. THE REASON FOR THE REVISION WAS UNREPORTED. NO RELEVANT PATIENT INFORMATION OR PRODUCT INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23299887 ↗
• InjuryJul 8, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE SURGEON PERFORMED A FULL REVISION ON THE PATIENT DUE TO PAINFUL SYNOVITIS, EXTENSIVE GRANULOMA, ABNORMAL WEAR OF THE PE REQUIRING EXCISION, FEMORAL AND TIBIAL OSTEOLYSIS, AND TIBIAL AND FEMORAL BONE GRAFT. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 22440791 ↗
• InjuryJul 1, 2025Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ASEPTIC PATELLA LOOSENING AND LYSIS AROUND THE PATELLA BUTTON WITH DISPLACED FRAGMENTATION OF THE SUPERIOR POLE. AS A RESULT, APPROXIMATELY 5.5 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT IS REHABILITATING THROUGH QUADRICEPS EXERCISES. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE. THIS IS 1 OF 3 EVENTS FOR THIS PATIENT.

  Patient problems: Aseptic loosening; Osteolysis

  MAUDE report 22376749 ↗
• InjuryJun 23, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS AND 4 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MILD OSTEOLYSIS WAS PRESENT. THE PATELLA EXHIBITED MILD WEAR ALONG THE LATERAL TRACKING PATH. THE TIBIAL INSERT HAD MILD WEAR MEDIALLY AND POSTERIOR TO THE POST. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. THE TIBIAL AND FEMORAL COMPONENTS WERE RETAINED, WHILE THE PATELLA AND TIBIAL INSERT COMPONENTS WERE REPLACED. THE PATIENT WAS REVISED TO EXACTECH 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: Osteolysis; Synovitis

  MAUDE report 22312459 ↗
• InjuryJun 23, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH INCREASING KNEE PAIN, A SENSE OF INSTABILITY, AND SWELLING. PLAIN RADIOGRAPHS REVEALED POLYETHYLENE WEAR, LOOSENING OF BOTH THE FEMORAL AND TIBIAL COMPONENTS, AND OSTEOLYSIS AFFECTING BOTH BONES. DURING THE REVISION PROCEDURE, A FEMORAL AND TIBIAL BONE DEFECT WAS IDENTIFIED CONSISTENT WITH AORI TYPE 2B. THERE WAS ALSO A SIGNIFICANT PATELLAR DEFECT AND A NOTABLE SOFT-TISSUE REACTION CHARACTERIZED BY SYNOVITIS. THE PATIENT WAS REVISED TO 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 RETURN. NO FURTHER INFORMATION. THIS IS 1 OF 4 REPORTS

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

  MAUDE report 22312287 ↗
• InjuryJun 9, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 71 YO MALE PATIENT, WHO HAD AN INITIAL LEFT TOTAL KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE, APPROXIMATELY 5 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS ON THEIR LEFT PRIMARY KNEE INCLUDING PAIN AND DISSATISFACTION. IT WAS DETERMINED THE IMPLANTED POLY WAS PART OF THE RECALL. THE PATIENT UNDERWENT A POLY SWAP AND PATELLA SWAP. THE PATIENT WAS REVISED TO A SIZE 13MM CRC POLY FOR SZ 3.5 AND A 35MM ROUND 3 PEG CEMENTED PATELLA. THERE WERE NO SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WAS RETURNED FOR ANALYSIS. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE L

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 22172188 ↗
• InjuryJun 9, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA. THE PATIENT WAS REVISED APPROXIMATELY 30 MONTHS DUE TO POLY WEAR. 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: Ambulation or Postural Difficulties; Implant Pain; Swelling/ Edema

  MAUDE report 22167937 ↗
• InjuryJun 5, 2025Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. 5 YEARS FOLLOWING IMPLANTATION, THE PATIENT EXPERIENCED ASEPTIC PATELLA LOOSENING AND LYSIS AROUND THE PATELLA BUTTON WITH DISPLACED FRAGMENTATION OF THE SUPERIOR POLE OF PATELLA; AND 9 MONTHS LATER, THE PATIENT HAD AN ARTHROSCOPY AND DEBRIDEMENT WITH BIOPSY TO LEFT KNEE FOR POLYETHYLENE WEAR WITH EVIDENCE OF OSTEOLYSIS. SUBSEQUENTLY, THE PATIENT IS AGAIN EXPERIENCING POLYETHYLENE WEAR WITH EVIDENCE OF OSTEOLYSIS. AS A RESULT, APPROXIMATELY 8 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A LEFT KNEE REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Osteolysis

  MAUDE report 22153557 ↗
• InjuryMay 12, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 12 YEARS POST INITIAL OPERATION. FEMUR WAS FOUND TO BE LOOSE. ALL COMPONENT WERE REMOVED AND REVISED TO A COMPETITOR'S DEVICE. THE PATIENT WAS IN STABLE CONDITION AND HAD NO KNOWN ISSUES WITH THE SURGERY. NO FURTHER INFORMATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22003311 ↗
• InjuryMay 9, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 82 YO MALE PATIENT, WHO HAD A RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 8 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POLY WEAR AS WELL AS FLAKING AND DELAMINATION. THE PATIENT WAS REVISED TO A 38MM PATELLA, AND THE TIBIAL INSERT WAS REVISED TO A SZ 4, 11MM. FRAGMENTS OF POLYETHYLENE WERE PRESENT IN THE KNEE JOINT WHICH THE SURGEON REMOVED. X-RAYS WERE PROVIDED. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS. THE SURGEON KEPT THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21994060 ↗
• InjuryApr 1, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6.72 YEARS SINCE INITIAL IMPLANT, THIS MALE PATIENT WITH BMI 36.3 UNDERWENT A LEFT SIDE TOTAL KNEE REPLACEMENT. THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21743235 ↗
• InjuryMar 31, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A FEMALE PATIENT, WHO HAD AN INITIAL LEFT KNEE IMPLANT PROCEDURE IN (B)(6) 2023 AND HAD UNDERGONE A SURGICAL PROCEDURE TO REPAIR A ¿FLOATING KNEECAP¿, PROBABLY DUE TO FAILED SUTURES ACCORDING TO THE SURGEON, INDICATED THAT 2 WEEKS LATER AN X-RAY INDICATED THAT THE REPAIR HAD FAILED. DURING A FOLLOW UP ON (B)(6) 2024, THE SURGEON STATED THE IMPLANT WAS NORMAL. HE DID NOT KNOW WHY THIS OCCURRED AND PROVIDED OPTIONS OF WEARING A BRACE FOR THE REST OF THE PATIENT¿S LIFE OR TO HAVE THE ENTIRE SURGERY REDONE. THE PATIENT INDICATED SHE NO LONGER SEES THIS SURGEON, AND THEY ARE ON THEIR 4TH EPISODE OF PHYSICAL THERAPY AND WILL BE ESSENTIALLY DISABLED THE REST OF THEIR LIFE. NO FURTHER INFORMATION. THIS IS 1 OF 2 EVENTS. SEE MDR#1038671-2025-01673 FOR (B)(6) 2024 EVENT.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 21732832 ↗
• InjuryMar 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY A FEMALE PATIENT, THAT THEY HAD A FAILED SURGERY FOLLOWING A LEFT KNEE IMPLANT PROCEDURE THAT OCCURRED IN (B)(6) 2023, RESULTING IN A DISLOCATED PATELLA. THEY REPORTED POOR BALANCE, UNABLE TO SIT OR STAND, DO STAIRS, AND BASICALLY WALK PROPERLY. ON (B)(6) 2024, AN X-RAY WAS REQUESTED WHICH INDICATED A ¿FLOATING KNEECAP¿. DURING FOLLOW-UP WITH THE SURGEON, HE INDICATED THAT THIS WAS VERY RARE, PROBABLY DUE TO FAILED SUTURES, AND HE COULD FIX IT IN ANOTHER PROCEDURE. THE PATIENT UNDERWENT A PROCEDURE TO REPAIR THE FLOATING KNEECAP ON (B)(6) 2024. 2 WEEKS LATER AN X-RAY INDICATED THAT THE REPAIR HAD FAILED. DURING A FOLLOW UP ON (B)(6) 2024, THE SURGEON STATED THE IMPLANT WAS NORMAL. HE DID NOT KNOW WHY THIS OCCURRED AND PROVIDED OPTIONS OF WEARING A BRACE FOR THE REST OF THE PATIENT¿S LIFE OR TO HAVE THE ENTIRE SURGERY REDONE. THE PATIENT INDICATED SHE NO LONGER SEES THIS SURGEON, AND THEY ARE ON THEIR 4TH EPISODE OF PHYSICAL THERAPY. NO FURTHER INFORMATION. THIS IS 1 OF 2 EVENTS.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Loss of Range of Motion; Subluxation

  MAUDE report 21702658 ↗
• InjuryMar 26, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 68 YO MALE PATIENT, INITIAL RIGHT TKA ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 7 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR TOTAL KNEE REPLACEMENT. THE PATIENT HAD A RECALLED POLYETHYLENE IMPLANT. THE PATIENT WAS SCHEDULED FOR A REVISION TKA, POSSIBLE POLYETHYLENE SWAP. THE PATIENT UNDERWENT A TIBIAL POLYETHYLENE IMPLANT SWAP AND A PATELLA IMPLANT SWAP. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE SENT TO THE LAB AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS. SEE MDR#1038671-2025-01668 FOR ADDITIONAL DEVICE REPORT.

  Patient problems: Discomfort; Loss of Range of Motion; Pain

  MAUDE report 21702261 ↗

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-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-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-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