Optetrak 208-24-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862054340), received between Dec 21, 2021 and Dec 22, 2025 — classified as 6 injuries.

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

2 FDA recall records name this device's identifier, 2 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 21, 2023Open, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0582-2024 · Root cause: Packaging change control · FDA record ↗

2. Aug 30, 2021Open, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0019-2022 · Root cause: Process control · 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.

• InjuryDec 22, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY WITH A COMPETITOR'S DEVICE. SUBSEQUENTLY, THE PATIENT DEVELOPED AN INFECTION AND WAS REVISED TO EXACTECH DEVICE. AFTER BEING CONVERTED TO EXACTECH DEVICES, THE PATIENT THEN DEVELOPED PAIN AND POLY WEAR RESULTING IN ANOTHER REVISION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 23866650 ↗
• InjuryJun 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 48 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Scar Tissue; Synovitis

  MAUDE report 19595038 ↗
• InjurySep 26, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION OF (B)(6) 2016. APPROXIMATELY 6 YEARS AND 9 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND RIGHT KNEE REVISION ON (B)(6) 2023. 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 MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Bone Fracture(s); Insufficient Information; Pain; Synovitis

  MAUDE report 17815843 ↗
• InjuryMay 21, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON 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 208-24-13-INSERTO TIBIAL CC 4,13MM, SERIAL NUMBER: (B)(6) ON (B)(6) 2021. THE INSERT WAS MANUFACTURED ON 21-AUG-2018 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 21-AUG-2018 AND WAS 2.5 YEARS SHELF AGE AT THE TIME OF IMPLANT. APPROXIMATELY TWO 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 16971213 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2.52 YEARS POST LEFT SIDE TKA, THIS MALE PATIENT UNDERWENT REVISION DUE TO PERSISTENT STIFFNESS. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. 510K: K954208.

  Patient problems: Failure of Implant

  MAUDE report 13428194 ↗
• InjuryDec 21, 2021Naturally Worn; Naturally Worn

  DURING OFFICE VISIT, SURGEON DID A CONDYLAR CONSTRAINED LINER EXCHANGE ON A REVISION HE DONE IN 2003, ON (B)(6) 2021. THIS WAS A LINER EXCHANGE OF A SIZE 4/13 MM CONDYLAR CONSTRAINED INSERT. THE LINER HAD MEDIAL WEAR. ALSO THE SPINE STIFFENING SCREW HAD SHEARED OFF AT THE THREADED JUNCTION OF THE SCREW. SURGEON WAS UNABLE TO RETRIEVE THE REST OF THE SCREW THAT WAS LOCKED INTO THE STEM AND TIBIAL TRAY. THIS DID NOT AFFECT THE INSERTION OF A NEW CONDYLAR CONSTRAINED LINER, BUT WAS UNABLE TO PLACE A NEW SPINE STIFFENING SCREW IN DUE TO THE BROKEN PIECE STILL IN THERE. THERE WAS NO BREAKAGE TO DEVICE. THERE WAS NO SURGICAL DELAY OR PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 13057292 ↗