Optetrak 200-63-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862041067), received between Dec 14, 2021 and Nov 20, 2024 — classified as 6 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.

5 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 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 9 YEARS POST INITIAL LEFT TOTAL KNEE ARTHROPLASTY (TKA) USING CR SLOPE WITH TIBIAL INSERT, THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN. THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERT, THEN REVISION SURGERY FOR THE REPLACEMENT OF ALL KNEE DEVICE WAS PERFORMED. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT. ALSO, DAMAGE WAS OBSERVED IN POSTERIOR OF TIBIAL TRAY DUE TO CONTACTING TO THE FEMORAL COMPONENT. THE SURGEON DECIDED TO REPLACE ALL COMPONENTS WITH A COMPETITOR PROSTHESIS. THE TIBIAL TRAY WAS DAMAGED AND FOUND METAL POWDER. THE SURGEON RETRIEVED AND CLEANED IT APPROPRIATELY DURING THE SURGERY. THE PATIENT'S BONE QUALITY WAS NORMAL AND THE PATIENT HAD HIGH ACTIVITY LEVEL. IT WAS ALSO NOTED THAT THE PATIENT HAD NOT WORN A KNEE BRACE FOLLOWING SURGERY. THE EVENT DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint effusion; Pain

  MAUDE report 20737480 ↗
• InjuryNov 27, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2010. APPROXIMATELY 6 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON 29 NOV 2017. 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. 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 LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A

  Patient problems: Insufficient Information

  MAUDE report 18209473 ↗
• InjurySep 7, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2015. ABOUT 8 YEARS LATER THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN AND THE SURGEON DIAGNOSED WEAR OF THE TIBIAL INSERT. THE PATIENT WAS REVISED ON (B)(6) 2023 AND THE TIBIAL INSERT WAS REPLACED. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT. HE DECIDED THERE WAS NO PROBLEM WITH THE LOCKING MECHANISM OF THE TIBIAL TRAY. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 17706478 ↗
• InjuryApr 18, 2023Fracture; Unstable; Naturally Worn; Fracture; Unstable; Naturally Worn

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis; Swelling/ Edema

  MAUDE report 16763722 ↗
• InjuryMar 27, 2023Material Integrity Problem; Naturally Worn; Material Integrity Problem; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED BY THE LEGAL DEPARTMENT ON 28 FEB 2023: ON (B)(6) 2012, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT WITH AN EXACTECH KNEE DEVICE. ON (B)(6) 2017, APPROXIMATELY 5 YEARS LATER THE PATIENT UNDERWENT REVISION OF THE RIGHT EXACTECH KNEE DEVICE SECONDARY TO SIGNIFICANT POLYETHYLENE LINER WEAR WITH RESULTING METALLOSIS, OSTEOLYSIS, AND SYNOVITIS. IT IS ALSO STATED THAT DESPITE UNDERGOING THE REVISION SURGERY, THE PATIENT EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS QUALITY OF LIFE. 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; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16617465 ↗
• InjuryDec 14, 2021Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, SALES REP INFORMED THAT THERE IS A PLAN THAT THE RECALL INSERT WILL RETRIEVE AT REVISION SURGERY AROUND WEEK AFTER NEXT DUE TO POSTERIOR WEAR OF THE INSERT.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 13005620 ↗

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-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-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-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-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-