Optetrak 208-25-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862054425), received between Nov 7, 2019 and Sep 18, 2024 — classified as 9 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.

1 other recall cover devices cleared under the same FDA submission (K954208); 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 16, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA CASE-(B)(4) LK REV 1 IS ASSOCIATED WITH THIS CASE. CASE-(B)(4), LK REV 2 IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED THAT APPROXIMATELY 198 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAINFUL RIGHT KNEE REPLACEMENT, OSTEOLYSIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0019-2022.

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

  MAUDE report 20251493 ↗
• InjurySep 18, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA . PATIENT ID: (B)(6) + LEFT KNEE REV 1. (B)(4), LK REV 2, (B)(4), RK REV IS ASSOCIATED WITH THIS CASE. IT IS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT IS VERIFIED BILATERAL KNEES DONE BY (B)(6), MD AT (B)(6). REVISION LEFT KNEE #1 ON (B)(6) 2016, REVISION LEFT KNEE #2 ON (B)(6) 2024 AND REVISION RIGHT KNEE (B)(6) 2024. LK REVISION 1 OP NOTES: PRE/POST OP DIAGNOSIS: FAILED LEFT TOTAL KNEE REPLACEMENT SECONDARY TO SAGITTAL INSTABILITY AND POLYETHYLENE WEAR WITH OSTEOLYSIS. PROCEDURE: REVISION LEFT TOTAL KNEE REPLACEMENT, POLYETHYLENE EXCHANGE. INDICATIONS: THIS IS 60-YEAR-OLD GENTLEMAN PRESENTED APPROXIMATELY NINE YEARS FOLLOWING NONMODULAR CCK TOTAL KNEE REPLACEMENT WITH A COMPLAINT OF RECENT ONSET SWELLING, MODERATE DISCOMFORT IN THE KNEE AND A SENSE OF INSTABILITY. ON PHYSICAL EXAMINATION, HE HAD MODERATE SYNOVIAL EFFUSION WHICH WAS TAPPED AND FOUND TO BE CLEAR SYNOVIAL FLUID. HE HAD BOTH CORONAL AND SAGITTAL INSTABILITY WITH AN ANTERIOR DRAWER GREATER THAN 10MM WITH THE KNEE FLEXED 90 DEGREES. OPERATIVE FINDINGS: WE FOUND SYNOVIAL EXPANSION DUE TO WHAT APPEARED TO BE POLYETHYLENE DEBRIS. THER WAS NO EVIDENCE OF INFECTION. THE TIBIAL AND FEMORAL COMPONENTS

  Patient problems: Discomfort; Joint Laxity; Joint effusion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 20246046 ↗
• InjuryJun 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 83 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19472970 ↗
• InjuryOct 12, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 59 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2011, WHO WAS REVISED ON (B)(6) 2016, UNDERWENT A 2ND REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 6 YEARS 10 MONTHS POST THE FIRST REVISION PROCEDURE. THE PATIENT HAD PAIN, RECURRENT AND PROGRESSIVE EFFUSIONS, AND INSTABILITY. THE PATIENT WAS REVISED TO A 208-25-18 CC TIBIAL INSERT SZ 5 18MM. NO DEVICE IMAGES OR X-RAYS WERE PROVIDED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED FOR ANALYSIS DUE TO THE HOSPITAL POLICY. NO FURTHER INFORMATION. THE FIRST REVISION WAS REPORTED UNDER MDR 1038671-2022-01080.

  Patient problems: Fluid Discharge; Joint Laxity; Joint effusion; Pain

  MAUDE report 17924976 ↗
• InjuryApr 17, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION 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 AND 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. NO DEVICE RETURNS ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

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

  MAUDE report 16758731 ↗
• InjuryMar 8, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, IN SPRING 2017, UNDERWENT A REVISION SURGERY ON HIS RIGHT KNEE FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. IN FALL 2022, APPROXIMATELY 5 YEARS POST REVISION PROCEDURE, PLAINTIFF UNDERWENT A REVISION SURGERY ON HIS RIGHT KNEE FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Implant Pain; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16504761 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL LEFT TOTAL KNEE REPLACEMENT IN APPROXIMATELY 2012 AND WAS IMPLANTED WITH AN OPTETRAK DEVICE. IN SPRING 2016, APPROXIMATELY 4 YEARS POST INITIAL PROCEDURE, PLAINTIFF UNDERWENT TWO REVISION SURGERIES ON HIS LEFT KNEE FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Implant Pain

  MAUDE report 16502464 ↗
• InjuryMar 8, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2012 AND WAS IMPLANTED WITH AN OPTETRAK POLYETHYLENE TIBIAL INSERT. ON (B)(6) 2022, PLAINTIFF UNDERWENT RIGHT KNEE REVISION SURGERY, APPROXIMATELY 10 YEARS 5 MONTHS POST INITIAL PROCEDURE, DUE TO ¿OSTEOLYSIS,¿ ¿ASEPTIC LOOSENING OF [THE] FEMORAL COMPONENT¿ AND ¿WEAR OF THE [POLYETHYLENE] LINER WITH DELAMINATION.¿ PLAINTIFF'S RIGHT KNEE REVISION SURGERY WAS DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK POLYETHYLENE TIBIAL INSERT. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16502352 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  THE SURGEON OPENED THE JOINT IN STANDARD FASHION. THE SURGEON TOOK OUT THE POLY INSERT AND SCREW. THE SURGEON THEN CUT THE PATELLA BUTTON OFF AND REPLACED IT WITH ONE SIZE SMALLER THAN THE PATIENT HAD IN. THE SURGEON THEN TRIALED OTHER POLYS AND DECIDED TO UP-SIZE TO AN 18 FROM A 13. THE SURGEON THEN LOCKED THE NEW POLY IN AND SCREWED IN THE CORRESPONDING SCREW. THE SURGEON THEN CLOSED THE KNEE IN STANDARD FASHION. THE SURGEON DID THE REVISION BECAUSE THE PATIENT WAS COMPLAINING OF PAIN. THE SURGEON THOUGHT IT WAS FROM SCAR TISSUE AROUND THE PATELLA BUTTON AND LAXITY IN FLEXION WHICH IS WHY THE SURGEON DID THE THINGS THAT THE SURGEON DID. IMPLANTS WERE THROWN OUT AFTER THE CASE. THE PATIENT WAS STABLE WHEN LEAVING THE OPERATING ROOM.

  Patient problems: No Code Available; Pain; Scar Tissue

  MAUDE report 9289498 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954208. One submission often covers many models, so check the product and lot details in each record.

• 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-