Optetrak 208-22-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862054203), received between Dec 22, 2021 and Sep 20, 2024 — classified as 7 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 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044) (B)(4), RK REV 2 IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 6 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS, MENTAL AND EMOTIONAL DISTRESS. 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 1522153 IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0019-2022.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 20271229 ↗
• InjuryJul 31, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 100 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR PLAINTIFF HAS EXPERIENCED DAILY PAIN AND DISCOMFORT IN HIS RIGHT KNEE WHICH HAS LIMITED HIS ACTIVITIES OF DAILY LIVING AND IMPACTED HIS QUALITY OF LIFE. PLAINTIFF HAS SUFFERED DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGONING MEDICAL CARE. AS A FURTHER DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPETRAK LOGID DEVISE. PLAINTIFF WAS SUSTAINED AND WILL SUSTAIN FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE; REHABILITATE, HOME HEALTH CARE; LOSS OF EARNING CAPACITY, MENTAL AND EMOTIONAL DISTRESS; AND PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Emotional Changes; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19872621 ↗
• InjuryJun 28, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION FROM OPERATIVE REPORT-THE PATIENT WAS REVISED TO COMPETITOR'S DEVICES. USING A COMBINATION OF A SMALL SAW AND OSTEOTOMES, THE FEMORAL IMPLANT WAS REMOVED WITH MINIMAL BONE LOSS. THE TIBIA WAS REMOVED WITH MINIMAL BONE LOSS. RECONSTRUCTION-GIVEN THE SIGNIFICANT POST-TRAUMATIC DEFORMITY AND BONE LOSS, A HINGED KNEE REPLACEMENT WAS INDICATED. ENOUGH RESIDUAL DISTAL FEMUR WAS PRESENT, THUS THE DECISION TO USE A DISTAL FEMORAL REPLACEMENT WAS DEFERRED. EXTENSIVE SCAR TISSUE AND OSTEOLYTIC BONE WAS REMOVED. THE PATELLA WAS THEN DEBRIDED OF SCAR TISSUE AND THE BUTTON WAS REMOVED WITH A SAW. DEVICES WERE TRIALED AND THEN IMPLANTED.

  Patient problems: Failure of Implant; Osteolysis; Scar Tissue

  MAUDE report 17217109 ↗
• InjuryApr 12, 2023Mechanical Problem; Unstable; Device Dislodged or Dislocated; Naturally Worn; Insufficient Device Problem Information; Mechanical Problem; Unstable; Device Dislodged or Dislocated; Naturally Worn; Insufficient Device Problem Information

  LEGAL CASE - (B)(6) RELATED CASES: (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION: REVISION SURGERY (B)(6) 2010, RE-REVISION SURGERY (B)(6) 2018 APPROXIMATELY 7 YEARS AND 10 MONTHS AFTER THEIR FIRST REVISION SURGERY. POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE REPLACEMENT OVER THE LAST FEW MONTHS, PATIENT WAS HAVING INCREASING PAIN IN THE LEFT KNEE. MULTIPLE ASPIRATIONS WERE NEGATIVE FOR ELEVATED CELL COUNT AND ALL CULTURES WERE NEGATIVE. IMAGING WAS CONSISTENT WITH EXTENSIVE LEFT KNEE SYNOVITIS WITH OSTEOLYSIS, CONCERNING FOR ASEPTIC OSTEOLYTIC REACTION. THE PATIENT WAS INDICATED FOR SURGERY. EXTENSIVE SCARRING WAS NOTED. EXTENSIVE GREY/BLACK SYNOVIUM WAS NOTED THROUGHOUT THE JOINT CONSISTENT WITH METALLOSIS REACTION. THE SCARRED REMNANTS PATELLAR FAT PAD WAS EXCISED. THE FEMORAL AND TIBIAL IMPLANTS WERE NOT LOOSE. UPON THEIR REMOVAL, SEVERAL UNDERLYING, CONTAINED AREAS OF OSTEOLYSIS WERE IDENTIFIED AND CURRETTED OUT. THE PATELLAR BUTTON HAD SOME DELAMINATION OF THE POLYETHYLENE, BUT WAS MOSTLY INTACT, WITH ONLY SLIGHT DEFORMATION ON THE LATERAL ASPECT. IT WAS KEPT IN PLACE. REVISED TO SMITH AND NEPHEW/STRYKER. PATIENT WAS TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION. THERE I

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 16727994 ↗
• InjuryOct 6, 2022Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S KNEE WAS REVISED 10 YEARS POST OP. NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 15549826 ↗
• InjurySep 1, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL, THAT THIS PATIENT'S RIGHT KNEE WAS REVISED 09/01/2015. SECOND REVISION DATE: (B)(6) 2021; REASON FOR THE REVISION WAS NOT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. FIRST REVISION REPORTED UNDER REPORT # 1038671-2022-00990.

  Patient problems: Insufficient Information

  MAUDE report 15334372 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, (B)(6) YEARS OLD MALE PATIENT RETURNED WITH KNEE PAIN AND INSTABILITY. SALES REP. WAS ALERTED BY SURGEON¿S OFFICE THAT HE WANTED TO PERFORM A FEMORAL REVISION ON AN OPTETRAK CCK. DUE TO THE FACT THAT THERE WAS AN OFFSET TIBIA IN THE PATIENT AND IT WAS DECIDED TO USED THE OLD CCK. THE FEMORAL COMPONENT WAS REMOVED. THE FEMUR WAS RECUT AND 20MM DISTAL AUGMENTS WERE USED (UP FROM 15MM). STEM LENGTH WAS INCREASED FROM 120MM TO 160MM AND AN APPROPRIATE CCK INSERT, AND OFFSET SCREW WERE USED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13061569 ↗

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-