Optetrak 200-23-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862040275), received between Oct 19, 2022 and Aug 14, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 reports).

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

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.

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

• InjuryAug 14, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2012. APPROXIMATELY 10 YEARS AND 8 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: FAILED RIGHT KNEE. THERE WAS A LARGE NON BLOODY EFFUSION AND EXTENSIVE SYNOVITIS THROUGHOUT THE ENTIRE KNEE. THERE WAS GROSS POLYETHYLENE WEAR ON THE TIBIAL INSERT AND FLAKES OF POLYETHYLENE SCATTERED THROUGHOUT THE KNEE. PATELLAR COMPONENT WAS IN GOOD CONDITION WITH NO SUBSTANTIAL WEAR. THE FEMORAL AND TIBIAL COMPONENTS WERE EACH REMOVED WITH MINIMAL IATROGENIC BONE LOSS. ON THE FEMORAL SIDE THERE WAS SUBSTANTIAL OSTEOLYSIS WITH NEAR COMPLETE LOSS OF BOTH POSTERIOR CONDYLES AND EXTENSIVE ANTERIOR BONE LOSS UNDER THE FEMORAL FLANGE.

  Patient problems: Failure of Implant; Implant Pain; Joint effusion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 17539586 ↗
• InjuryMay 19, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN INPERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT ((B)(6)) WAS IMPLANTED WITH A 200-23-15-INSERTO TIB CR 3, 15MM, SERIAL NUMBER (B)(4) ON (B)(6) 2014. THE INSERT WAS MANUFACTURED ON 7/7/2010 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 7/7/2010 AND WAS 4.2765229295003424 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6) 2023, APPROXIMATELY 9.0 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16964779 ↗
• InjuryMar 29, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTS THAT ON (B)(6) 2011 A FEMALE PATIENT UNDERWENT A LEFT KNEE TOTAL ARTHROPLASTY, THEN ON (B)(6) 2012 THE PATIENT UNDERWENT A REVISION OF THE EXACTECH NET COMPRESSION MOLDED, POSTERIOR STABILIZED TIBIAL INSERT, AND EXACTECH CONSTRAINED CONDYLAR FEMORAL COMPONENT, APPROXIMATELY 1 YEAR 20 DAYS AFTER IMPLANT. IT IS STATED THAT DESPITE UNDERGOING THE REVISION SURGERIES, 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; Discomfort; Insufficient Information; Metal Related Pathology; Pain; Unspecified Infection

  MAUDE report 16640121 ↗
• InjuryOct 19, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THIS 66 Y/O MALE PATIENT HAD BOTH RIGHT AND LEFT PRIMARY CR TKA'S DONE IN 2012. THE PATIENT PRESENTED TO SURGEON'S OFFICE ORIGINALLY FOR HIS RIGHT KNEE, HAVING PAIN, SWELLING, AND STIFFNESS. SURGEON PERFORMED A RIGHT TOTAL KNEE REVISION TKA ON THE PATIENT. THE PATIENT HAD EVIDENT OSTEOLYSIS AND POLY WEAR ON THE X-RAY. THE DATE OF THE RIGHT KNEE REVISION WAS NOT GIVEN. THE SURGEON SAID THAT THE ORIGINAL POLY WAS DESTROYED WHEN REMOVED AND THE PATIENT HAD SUBSTANTIAL LYSIS IN THE TISSUES AND BONES. THE RIGHT KNEE TIBIA IMPLANT WAS LOOSE AND SO HE REVISED THE PRIMARY TKA TO A REVISION TKA OF ANOTHER COMPANY. THE PATIENT PRESENTS TO BE DOING WELL POST RIGHT KNEE TOTAL REVISION. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Aseptic loosening; Failure of Implant; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15633441 ↗
• InjuryOct 19, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THIS 66 Y/O MALE PATIENT HAD BOTH RIGHT AND LEFT PRIMARY CR TKA'S DONE IN 2012. APPROXIMATELY ELEVEN YEARS POST LEFT TKA, PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH THE START OF LEFT KNEE PAIN, STIFFNESS, AND SWELLING. THE PATIENT WAS SCHEDULED FOR A REVISION LEFT TKA POSSIBLE POLY SWAP. THE SURGEON DID NOT WANT THE ISSUE TO PERSIST OR POTENTIALLY CAUSE MORE DAMAGE IF THERE IS POLY WEAR/FAILURE HAPPENING. THE SURGEON OPENED THE KNEE, THERE WAS OBVIOUS LYSIS OF THE TISSUES AND CAPSULE. THE SURGEON PERFORMED A SYNOVECTOMY AND REMOVED ALL THE VISIBLY AFFECTED TISSUE. THE SURGEON EXPOSED THE PATELLA AND IT SHOWED TO BE WORN. THE SURGEON FELT THE PATELLA NEEDED TO BE REMOVED AND REPLACED. UPON REMOVAL AND EXAMINATION, THE POLY SHOWED TO BE DELAMINATED AND SHOWED PITTING OVER THE ARTICULAR SURFACE. THERE WAS SOME DISCOLORATION OF THE POLY AS WELL. THERE WERE OBVIOUS PIECES THAT WERE FLOATING IN THE JOINT. THE SURGEON AND ASSISTANTS REMOVED ALL THE PIECES THEY COULD SEE AND THEN HEAVILY IRRIGATED THE KNEE JOINT. THE SURGEON THEN USED A TAMP TO TEST AND HIT ON THE FEMORAL AND TIBIA COMPONENTS. CHECKING TO MAKE SURE THEY ARE OR ARE NOT LOOSE. THE FEMUR AND TIBIA COMPONENTS

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

  MAUDE report 15633262 ↗

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