Optetrak 244-23-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862063991), received between Oct 30, 2020 and Jan 12, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (8 reports).

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

3 other recalls cover devices cleared under the same FDA submission (K033883); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Naturally Worn

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY APPROXIMATELY 10 YEARS AGO. BEGINNING THIS YEAR, THE PAIN ESCALATED SIGNIFICANTLY, RESULTING IN SUBSTANTIAL FUNCTIONAL LIMITATION AND IMPAIRED AMBULATION. CONSEQUENTLY, SURGICAL DEBRIDEMENT TO REMOVE POLYETHYELENE WEAR DEBRIS WAS PERFORMED LAST WEEK.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 24044640 ↗
• InjuryJan 12, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 10 YEARS POST THE INITIAL TOTAL KNEE ARTHROPLASTY, THE PATIENT IS CURRENTLY EXPERIENCING SIGNIFICANT PAIN AND MOBILITY IMPAIRMENT. AN AP X-RAY FROM (B)(6) 2025 DEMONSTRATES MARKED NARROWING OF THE JOINT SPACE BETWEEN THE FEMORAL COMPONENT AND THE TIBIAL TRAY, WITH NOTABLE MEDIAL PROXIMITY OF THE METAL COMPONENTS. THESE FINDINGS ARE CONSISTENT WITH SEVERE THINNING OR FAILURE OF THE POLYETHYLENE TIBIAL INSERT. THE TREATING SURGEON HAS DETERMINED THAT REPLACEMENT OF THE TIBIAL INSERT IS MEDICALLY NECESSARY.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 24043076 ↗
• InjuryMar 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2007, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 15 YEARS AND 4 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Emotional Changes; Pain

  MAUDE report 18912087 ↗
• InjuryFeb 27, 2024Peeled/Delaminated; Unstable; Naturally Worn; Peeled/Delaminated; Unstable; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 11 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. APPROXIMATELY 5 YEARS AFTER THE INITIAL SURGERY, LYSIS IN THE TIBIAL IMPLANT WAS NOTED. APPROXIMATELY 9 YEARS AFTER INITIAL SURGERY, THE PATIENT EXPERIENCED PROGRESSIVE PAIN IN THEIR RIGHT KNEE. APPROXIMATELY 2 YEARS AFTER THE PAIN IN THEIR RIGHT KNEE, THE REVISION WAS PERFORMED. DELAMINATED POLYETHYLENE IN THE CENTRAL PIVOT AND BROKEN PATELLA POLY WAS INDICATED. THE PATIENT WAS REVISED WITH A COMPETITOR¿S DEVICES. NO PARTS OR PIECES FELL INTO PATIENT WOUND SITE AND THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION DURING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THE SURGEON DID NOT WANT TO PROVIDE THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Implant Pain; Osteolysis; Pain

  MAUDE report 18789599 ↗
• InjuryJun 26, 2023Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A BILATERAL KNEE REPLACEMENT ON (B)(6) 2008. APPROXIMATELY 14 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: BILATERAL KNEE DISCOMFORT, PAINT, RESTRICTED MOTION, STIFFNESS SWELLING INSTABILITY, OSTEOLYSIS, POLYMERIC WEAR INDUCED SYNOVITIS; LEFT KNEE VARUS DEFORMITY. 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. EBI INITIAL SURGERY SEARCH - NO RESULTS.

  Patient problems: Failure of Implant; Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17198349 ↗
• InjuryJun 26, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A BILATERAL KNEE REPLACEMENT ON (B)(6) 2008. THE PATIENT WILL REQUIRE A REVISION SURGERY FOR THE RIGHT KNEE IN THE NEXT 12-16 MONTHS. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: BILATERAL KNEE DISCOMFORT, PAINT, RESTRICTED MOTION, STIFFNESS SWELLING INSTABILITY, OSTEOLYSIS, POLYMERIC WEAR INDUCED SYNOVITIS; LEFT KNEE VARUS DEFORMITY. AS A CONSEQUENCE OF DEFECTS IN THE AFORESAID COMPONENTS, THE PLAINTIFF UNDERWENT LEFT SIDED REVISION SURGERY ON (B)(6) 2023, WITH REMOVAL OF THE AFORESAID COMPONENTS. 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: Failure of Implant; Insufficient Information

  MAUDE report 17197554 ↗
• InjuryApr 18, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA THE LEGAL DEPARTMENT A 64 Y/O FEMALE PATIENT HAD A TOTAL LEFT KNEE REPLACEMENT ON (B)(6) 2010. APPROXIMATELY 12 YEARS AND 1 MONTH LATER THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. (B)(6) 2023 V SIMMS, RN- REVISION OP REPORT OF (B)(6) 2023 OP REPORT STATES RIGHT KNEE-THE STICKER SHEET OF REVISION DEVICES SHOW 2 LEFT DEVICES AND OTHER INFORMATION, INCLUDING THE DISCHARGE SUMMARY CLEARLY INDICATE THAT THE LEFT KNEE WAS REVISED. PRE-PROCEDURE DIAGNOSIS: TKA ASEPTIC LOOSENING, TKA WEAR OF ARTICULAR BEARING, AND PAIN THE MEDIAL LATERAL GUTTERS WERE REESTABLISHED WITH DEBRIDEMENT OF SYNOVITIS AND SCAR TISSUE. THE POLYETHYLENE LINER WAS REMOVED WITHOUT DIFFICULTY WHICH WAS NOTED TO HAVE WEAR AND DISCOLORATION. THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AND DISIMPACTED OFF THE DISTAL FEMUR WITHOUT DIFFICULTY. THE TIBIAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AND DISIMPACTED OFF THE TIBIAL PLATEAU WITHOUT DIFFICULTY. THE PATELLA WAS NOTED TO HAVE EXCELLENT TRACKING. DRESSINGS WERE APPLIED. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. DISCHARGED FROM HOSPITAL ON (B)(6) 2023 TO HOME TO FOLLOW UP WITH P

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

  MAUDE report 16762842 ↗
• InjuryMar 31, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6), 2008. IN THE ENSUING TIME, THE PATIENT BEGAN TO SUFFER FROM SYMPTOMS INCLUDING PAIN AND LACK OF MOBILITY. AS A RESULT OF THESE SYMPTOMS, THE PATIENT UNDERWENT A REVISION OF THE LEFT TOTAL KNEE ON (B)(6), 2020, APPROXIMATELY 12 YEARS 3 MONTHS POST INITIAL PROCEDURE. THE PATIENT EXPERIENCES, PAIN, LACK OF MOBILITY, AND ENDURING LIMITATIONS ON ACTIVITIES OF DAILY LIVING, QUALITY OF LIFE AND ABILITY TO PERFORM WORK FUNCTIONS. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

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

  MAUDE report 16657008 ↗
• InjuryOct 30, 2020Unstable; Unstable

  IT WAS REPORTED THAT A (B)(6) YO (DOB (B)(6)) AT (B)(6) KG PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2012, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2006. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10760088 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts,
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants