Optetrak 200-04-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862039699), received between Jun 27, 2021 and Dec 12, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K932776); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 96 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND DIFFICULTY WITH WEIGHTBEARING ACTIVITIES, AND INTERMITTENT SWELLING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT, AS THE COBALT CHROME FINISH OF THE FEMORAL WAS SCRATCHED DUE TO ARTICULATION WITH THE METAL OF THE TIBIA, AND THE POSTEROMEDIAL RIM OF THE TIBIA HAD REMODELING WHICH PREVENTED NEW POLYETHYLENE FROM SEATING PROPERLY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20915059 ↗
• InjuryNov 5, 2024Migration; Migration

  AS REPORTED, AFTER ABOUT SIX YEARS LATER FROM A PRIMARY SURGERY, THE PATIENT WHO HAD TOTAL KNEE ARTHROPLASTY USING CR SLOPE + TIBIAL INSERTS COMPLAINED KNEE SWELLING AND PAIN, THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERTS, THEN REVISION SURGERY FOR THE REPLACEMENT OF THE TIBIAL INSERTS FOR BOTH SIDE WERE PERFORMED (RIGHT KNEE REVISION REPORTED). SURGEON DECIDED THAT ALL EXACTECH¿S COMPONENT WAS REMOVED AND COMPETITOR¿S REVISION DEVICE WAS IMPLANTED FOR BOTH SIDE. POLYETHYLENE PARTICLES AND PROLIFERATIVE (GROWTH) TISSUES ON THE SURGICAL FIELD WERE RESECTED BY THE SURGEON APPROPRIATELY. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Implant Pain; Osteolysis; Swelling/ Edema

  MAUDE report 20615428 ↗
• InjurySep 6, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL TKA IN (B)(6) 2008. THE PATIENT WAS BROUGHT BACK FOR RIGHT KNEE PAIN, WHICH APPEARED TO BE TIBIAL LOOSENING. THE INSERT WAS REMOVED. THE FEMUR WAS CHECKED AND FOUND TO BE WELL FIXED. ATTENTION TURNED TO THE TIBIA AND IT WAS FOUND TO BE LOOSE. THE TIBIA WAS REMOVED. A NEW TIBIA, STEM AND INSERT WERE IMPLANTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Aseptic loosening; Failure of Implant; Pain

  MAUDE report 15361589 ↗
• InjuryJun 27, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 14 YRS POSTOP THE INITIAL RTKA, THE FEMALE PATIENT HAD HER TIBIA REVISED DUE TO LOOSENING. THE PATIENT RECEIVED A NEW TRULIANT REVISION TIBIA SIZE 1, 10 X80 BLASTED STEM, 10 MM TIBIAL AUGMENTS AND A SIZE 11 INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED DUE TO HOSPITAL DISCARDED THE IMPLANTS.

  Patient problems: Failure of Implant

  MAUDE report 12073183 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932776. One submission often covers many models, so check the product and lot details in each record.

• Z-0927-06 · Dec 19, 2005 · Terminated
  Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONL
• Z-1379-05 · Jun 2, 2005 · Terminated
  The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SING