Optetrak 200-02-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862039576), received between Oct 17, 2024 and Apr 10, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (8 reports).

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

4 other recalls cover devices cleared under the same FDA submission (K932690); 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. Apr 18, 2024Class IIOpen, Classified

   Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

   Z-2155-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS POST OP THE INITIAL RIGHT TKA, THIS 73 Y/O FEMALE PATIENT WAS REVISED DUE TO COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT HAD REVISION SURGERY ON (B)(6)2023. THE PATIENT UNDERWENT A RIGHT TKA TIBIAL POLY SWAP AND PATELLA IMPLANT SWAP. THE PATIENT LEFT THE OR STABLE FOLLOWING FULL REVISION. DEVICES ARE NOT RETURNING; THE IMPLANT IS REQUIRED TO GO TO THE LAB AND LEGAL AT THE HOSPITAL. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 24839877 ↗
• InjurySep 15, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL TOTAL KNEE REPLACEMENT. SUBSEQUENTLY, THE PATIENT WAS REVISED; REASON UNKNOWN. NO FURTHER INFORMATION PROVIDED. 510K:

  Patient problems: Insufficient Information

  MAUDE report 23057485 ↗
• InjuryMar 4, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 89 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, JOINT LAXITY, PAIN, AND SWELLING/EDEMA. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21518297 ↗
• InjuryJan 23, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 62 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DISTRESS, JOINT LAXITY, PAIN, SWELLING/EDEMA, AND SYNOVITIS. 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: Distress; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21217687 ↗
• InjuryDec 31, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY. THEY UNDERWENT RIGHT KNEE REVISION SURGERY APPROXIMATELY 1 YEAR 3 MONTHS AFTER THEIR INITIAL PROCEDURE. REVISION OP REPORT STATES THAT THERE WAS OBVIOUS EVIDENCE OF OXIDATION OF THE POLYETHYLENE WITH YELLOW DISCOLORATION. THERE WAS ALSO PITTING NOTED IN BOTH THE MEDIAL AND LATERAL MID PORTION OF THE POLYETHYLENE. THERE WAS NO EVIDENCE OF ANY LOOSENING OF THE ACTUAL COMPONENTS. IT WAS ALSO NOTED THAT THE POLYETHYLENE HEAD OF THE PATELLA HAD SOME LATERAL EDGE WEAR AND UPON FURTHER INSPECTION, IT APPEARED THAT THE BUTTON WAS PLACED MEDIAL AND IT WAS A SMALL BUTTON AND THERE WAS STILL RESIDUAL PATELLA. THE SURGEON NOTED IT LOOKED LIKE THE PATELLA DURING FLEXION AND EXTENSION, THE LATERAL FEMORAL CONDYLE WAS RIDING ON THE EDGE OF THE PATELLA AND WAS TRACKING ABNORMALLY RESULTING IN ABNORMAL PATELLA WEAR ON THE LATERAL EDGE OF THE PATELLA. THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. 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.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 21047706 ↗
• InjuryDec 9, 2024Fracture; Peeled/Delaminated; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Peeled/Delaminated; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 148 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PROGRESSIVE KNEE PAIN, OSTEOLYSIS, ASEPTIC LOOSENING OF FEMUR AND TIBIAL TRAY, POLYETHYLENE WEAR OF INSERT, SURFACE DAMAGE, DELAMINATION AND PITTING ON THE PATELLA, WHICH WAS FRACTURED AND LOOSE. 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: Implant Pain; Osteolysis

  MAUDE report 20878340 ↗
• InjuryNov 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 117 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, OSTEOLYSIS, FAILURE OF IMPLANT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 20760657 ↗
• InjuryOct 17, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 39 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. FOR A PERIOD OF YEARS AFTER HAVING HER EXACTECH LEFT KNEE REPLACEMENT, MS. (B)(6)' IMPLANT FUNCTIONED NORMALLY. EVENTUALLY, SHE BEGAN TO SUFFER FROM INCREASING PAIN, SWELLING AND INSTABILITY IN HER LEFT KNEE. ON (B)(6) 2009, MS. (B)(6) UNDERWENT A REVISION SURGERY TO ADDRESS HER FAILED EXACTECH DEVICE. THE REVISION PROCEDURE WAS PERFORMED BY DR. (B)(6) OF (B)(6)L MEDICAL CENTER AT (B)(6) HEALTH IN (B)(6). THE REVISING SURGEON REPLACED THE POLYETHYLENE TIBIAL INSERT AS WELL AS THE PATELLAR COMPONENT, NOTING THAT THE TIBIAL TRAY AND FEMORAL COMPONENTS WERE WELL FIXED AT THE TIME. FOLLOWING HER REVISION SURGERY, MS. (B)(6) UNDERWENT A LENGTHY AND PAINFUL RECOVERY. 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: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20476837 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932690. One submission often covers many models, so check the product and lot details in each record.

• Z-2156-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
• Z-2157-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
• Z-2158-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
• Z-0019-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-1