Optetrak 244-22-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862063977), received between Oct 15, 2020 and Dec 17, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 13 YEARS AND 12 DAYS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MODERATE OSTEOLYSIS WAS PRESENT. THE SURGEON REMOVED ALL OSTEOLYTIC TISSUE. THE PATELLA EXHIBITED SIGNIFICANT WEAR ALONG THE LATERAL AND MEDIAL TRACKING PATH AND HAD DISASSOCIATED FROM THE CEMENT. THE TIBIAL INSERT HAD MILD WEAR ON THE MEDIAL AND LATERAL ARTICULAR SURFACE. 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. 200-02-29 - THREE PEG PATELLA 29MM (B)(6). 244-22-13 - OPTETRAK HI-FLEX TIBIAL INSERT SZ 2 13MM (B)(6) CONCOMITANTS: 244-03-02 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, RIGHT (B)(6) 204-04-23 - TRAPEZOID TIBIAL TRAY SZ 1F/3T, 2F/3T (B)(6).

  Patient problems: Osteolysis; Synovitis

  MAUDE report 23827976 ↗
• InjuryMay 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 26 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, INSTABILITY, ASEPTIC LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity

  MAUDE report 19355267 ↗
• InjuryMay 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 163 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 19269089 ↗
• InjuryApr 23, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD A LEFT TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2012 AND THEN WAS REVISED ON (B)(6) 2023. THE PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE PROSTHESIS WEAR, COMPONENT LOOSENING, DEVICE FAILURE, REVISION SURGERY, JOINT PAIN, JOINT SWELLING, EFFUSION, INFLAMMATION, KNEE POPPING/CLUNKING, KNEE GIVING WAY, DIFFICULTY WALKING AND ANTALGIC GAIT. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

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

  MAUDE report 19162894 ↗
• InjuryOct 23, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2007. APPROXIMATELY 15 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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) 2022. DIAGNOSIS: RIGHT KNEE OSTEOLYSIS, INSTABILITY, LOOSENING FEMORAL COMPONENT AND POLYETHYLENE WEAR FINDINGS: SYNOVITIS CONSISTENT WITH POLY WEAR AND LOOSENING. NO GROSS EVIDENCE OF INFECTION. GLOBAL INSTABILITY WITH 3 DEG HYPEREXTENSION. DEBONDED LOOSE FEMORAL COMPONENT. SEVERE POLY WEAR WITH DELAMINATION AND FREE FRAGMENTS IN THE TISSUE. SEVERE OSTEOLYSIS FEMUR CENTRALLY WITH INVOLVEMENT OF BOTH CONDYLES WITH SUPPORTIVE DISTAL BONE AND REMAINING POSTERIOR CONDYLE STRUTS TYPE IIB BONE LOSS. OSTEOLYSIS TIBIA IIB. SEVERE OSTEOLYSIS PATELLA WITH INADEQUATE REMAINING BONE TO SUPPORT REVISION RESURFACING COMPONENT.

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

  MAUDE report 17983919 ↗
• InjuryJun 26, 2023Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2008 AND THEN APPROXIMATELY 11 YEARS, 1 MONTH LATER WAS REVISED ON (B)(6) 2019. REASON FOR REVISION WAS NOT PROVIDED. 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: Insufficient Information; Joint Laxity

  MAUDE report 17197826 ↗
• InjuryMay 25, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 8 YRS POSTOP THE INITIAL L TKA, THE SURGEON COMPLETED A L KNEE SCOPE ON THIS FEMALE PATIENT PREVIOUSLY AND NOTICED SEVERE DELAMINATION OF THE POLY. HE THEN SCHEDULED THE PATIENT FOR A POLY SWAP WHERE HE REMOVED THE CURRENT POLY AND PUT IN A NEW INSERT. THE PATIENT WANTED THE MOST MINIMAL FIX, MEANING SWITCHING OUT THE OLD INSERT FOR A NEW INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 11877855 ↗
• InjuryOct 15, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2010, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2008. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10687548 ↗

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 Inser
• 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