Optetrak 204-04-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862047724), received between Oct 7, 2020 and Apr 17, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 reports).

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED COMPLETE POLYETHYLENE LINER WEAR AND DELAMINATION LINER WITH RESULTING SYNOVITIS, CYST FORMATION, OSTEOLYSIS OF THE FEMUR AND TIBIA, AND ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. AS A RESULT, APPROXIMATELY SIX YEARS AND EIGHT MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. 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: Ambulation or Postural Difficulties; Aseptic loosening; Cyst(s); Metal Related Pathology; Osteolysis; Pain; Synovitis; Unspecified Infection; Unspecified Musculoskeletal problem

  MAUDE report 24913687 ↗
• InjuryJan 30, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD THEIR FIRST LEFT KNEE REVISION SURGERY ON (B)(6)2011. THEY SUBSEQUENTLY UNDERWENT A SECOND LEFT KNEE REVISION ON (B)(6)2017, APPROXIMATELY 5 YEARS 5 MONTHS AFTER THEIR PRECEDING REVISION. THE PATIENT CLAIMS TO HAVE SUFFERED PAIN SINCE THE IMPLANTED DEVICE AND CONTINUES TO FACE PAIN. 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; Joint Laxity; Pain; Scar Tissue; Synovitis

  MAUDE report 21275593 ↗
• InjuryNov 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2009. HE HAD LEFT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 13 YEARS 5 MONTHS AFTER THEIR INITIAL IMPLANTATION. HE HAS DEVELOPED PROGRESSIVE PAIN AND DEBILITATION RELATED TO HIS LEFT KNEE. HIS X-RAYS SHOWED WHAT APPEARED TO BE LOOSENING OF THE FEMORAL COMPONENT WITH DEBONDING OF THE ANTERIOR FLANGE WITH THE CEMENT MANTLE. THE PATELLAR COMPONENT WAS WELL FIXED HOWEVER WAS SEVERELY WORN AND THEREFORE, REPLACED. THE FEMORAL COMPONENT HAD SIGNIFICANT DEBONDING OF THE CEMENT PROSTHETIC INTERFACE UNDER THE ANTERIOR FLANGE AND WAS EASILY REMOVED. THERE ALSO APPEARED TO BE LOOSENING OF THE TIBIAL COMPONENT AS IT WAS REMOVED FROM ITS CEMENT MANTLE RELATIVELY EASILY. THE POLYETHYLENE LINER HAD MINIMAL WEAR EXCEPT FOR ON THE ANTERIOR PORTION OF THE TIBIAL SPINE. THERE WAS SYNOVIAL HYPERTROPHY CONSISTENT WITH COMPONENT LOOSENING. IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, DISCOMFORT, PAIN, SYNOVITIS, OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20663023 ↗
• InjuryOct 25, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE - (B)(6). IT WAS REPORTED THAT A 65 YO PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2014, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 8 YEARS POST THE INITIAL PROCEDURE. THE PATIENT HAD BEEN SEEN BY THE SURGEON IN AN OUTPATIENT CLINIC. THE PATIENT HAD CONSTANT PAIN AND INSTABILITY THAT FAILED CONSERVATIVE TREATMENT. THE PRE-PROCEDURE DIAGNOSIS INDICATED ASEPTIC LOOSENING OF COMPONENTS, ARTHROPLASTY WEAR OF THE POLYETHYLENE LINER. THE POLYETHYLENE WAS REMOVED WITH AN OSTEOTOME WITHOUT DIFFICULTY. THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AND WAS DIS-IMPACTED WITHOUT DIFFICULTY. THE TIBIAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AND WAS DIS-IMPACTED OFF THE TIBIAL PLATEAU WITHOUT DIFFICULTY AND THERE WAS MINIMAL BONE LOSS. THE TIBIAL STEM AND BONE CEMENT WERE REMOVED. COMPETITOR¿S DEVICES WERE RE-IMPLANTED. THE PATIENT WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT IN STABLE CONDITION WITH STABLE VITAL SIGNS HAVING TOLERATED THE PROCEDURE WELL WITHOUT APPARENT COMPLICATIONS. REVISED TO STRYKER. SERIAL #: (B)(6), CATEGORY #: 208-25-13 - CC TIBIAL INSERT SZ 5, 13MM, 510K: K954208; JWH; Z-0019-2022. CONCOMITANTS: SERIAL #: (B)(6), CATEGORY #: 20

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

  MAUDE report 20532799 ↗
• InjuryOct 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2010, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2003. THE PATIENT HAD BILATERAL KNEE ARTHROPLASTY. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10681641 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2006, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2002. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10641033 ↗

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-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-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-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.