Optetrak 208-23-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862054289), received between Sep 7, 2022 and Mar 27, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Naturally Worn” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 21, 2023Class IIOpen, 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 · Recall details · FDA record ↗

2. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 48 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, DISCOMFORT, OSTEOLYSIS, AND PAIN. INITIAL SURGERY AND 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.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Osteolysis; Pain

  MAUDE report 21710983 ↗
• InjuryJun 26, 2024Naturally Worn; Lack of Effect; Naturally Worn; Lack of Effect

  IT WAS REPORTED THAT APPROXIMATELY 16 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN. INITIAL SURGERY AND 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.

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

  MAUDE report 19612907 ↗
• InjuryJun 20, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 175 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, GROSSLY LOOSE FEMUR, TIBIAL INSERT, TIBIA, PATELLA, BROKEN POLY LOCKING SCREW, MASSIVE BONE LOSS IN THE FEMUR AND TIBIA, MARKED BONE LOSS IN THE PATELLA, ADVANCED WEAR AND OXIDATION ON TIBIAL INSERT AND PATELLA. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 19574248 ↗
• InjuryJun 20, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 175 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, GROSSLY LOOSE FEMUR, TIBIAL INSERT, TIBIA, PATELLA, BROKEN POLY LOCKING SCREW, MASSIVE BONE LOSS IN THE FEMUR AND TIBIA, MARKED BONE LOSS IN THE PATELLA, ADVANCED WEAR AND OXIDATION ON TIBIAL INSERT AND PATELLA. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 19574221 ↗
• InjuryJun 20, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 175 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, GROSSLY LOOSE FEMUR, TIBIAL INSERT, TIBIA, PATELLA, BROKEN POLY LOCKING SCREW, MASSIVE BONE LOSS IN THE FEMUR AND TIBIA, MARKED BONE LOSS IN THE PATELLA, ADVANCED WEAR AND OXIDATION ON TIBIAL INSERT AND PATELLA. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 19574164 ↗
• InjuryJun 20, 2024Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 175 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, GROSSLY LOOSE FEMUR, TIBIAL INSERT, TIBIA, PATELLA, BROKEN POLY LOCKING SCREW, MASSIVE BONE LOSS IN THE FEMUR AND TIBIA, MARKED BONE LOSS IN THE PATELLA, ADVANCED WEAR AND OXIDATION ON TIBIAL INSERT AND PATELLA. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 19574001 ↗
• InjuryJun 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 60 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DISCOMFORT, AND DIFFICULTY WALKING. PLAINTIFF HAS SUFFERED, AND MAY CONTINUE TO SUFFER, SEVERE AND PERMANENT PERSONAL INJURIES, INCLUDING POLYETHYLENE WEAR AND DEVICE FAILURE, PAINFUL KNEE REVISION SURGERY TO REMOVE OR REVISE THE DEFECTIVE DEVICE, CONTINUED REHABILITATION, MEDICAL CARE, AND POSSIBLE ADDITIONAL SURGERIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Implant Pain

  MAUDE report 19466379 ↗
• InjuryMay 17, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 48 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING OF THE PATELLAR COMPONENT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. DURING THE PROCEDURE, THE FEMORAL AND TIBIAL COMPONENTS WERE EXAMINED AND FOUND TO BE WELL FIXED WITH NO EVIDENCE OF LOOSENING. THERE WAS NOT ANY NOTE OF SIGNIFICANT SYNOVITIS OR SIGNS OF A LARGE EFFUSION ASSOCIATED WITH THE EXACTECH RECALL AND POLYETHYLENE PROBLEMS. THE DECISION WAS MADE TO LEAVE THE FEMORAL AND WELL FIXED TIBIAL COMPONENTS INTACT. THE PATIENT WAS REVISED WITH A COMPETITOR'S PATELLAR COMPONENT. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19344107 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY FIRST REVISION ON (B)(6) 2015, AND THEN EXPERIENCED SECOND REVISION SURGICAL PROCEDURE ON (B)(6) 2017 APPROXIMATELY 1 YEAR AND 8 MONTHS AFTER FIRST REVISION IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 18901178 ↗
• InjuryDec 19, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A FOURTH RIGHT KNEE REVISION ON (B)(6) 2013. THIS DEVICE HAS NOT BEEN EXPLANTED. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18354762 ↗
• InjurySep 7, 2022Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT MALE PATIENT, INITIALLY IMPLANTED WITH OPTETRAK KNEE REPLACEMENT SYSTEM IN 2011, EXACT DATE UNKNOWN, FOLLOWING SEEING NEWS THAT HIS KNEE REPLACEMENT WAS RECALLED, OBTAINED MRI¿S AND X-RAYS OF HIS KNEE WHICH CONFIRMED THAT THE RECALLED POLYETHYLENE INSERT HAD DEGRADED TO SUCH EXTENT THAT IT WAS CAUSING EXTENSIVE BONE DAMAGE. HE UNDERWENT REVISION SURGERY ON (B)(6) 2022 APPROXIMATELY 11 YEARS 6 MONTHS POST THE INITIAL PROCEDURE. THE KNEE REPLACEMENT SYSTEM WAS REMOVED, AND BONE RECONSTRUCTION WAS PERFORMED. NO DEVICES WILL BE RETURNING AS THE CUSTOMER RETAINS ALL DEVICES.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15374494 ↗