Optetrak 200-73-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862041265), received between Nov 29, 2022 and Sep 12, 2024 — classified as 6 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.

5 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 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 148 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, INSTABILITY, OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE." (B)(6) 200-73-11 - CR TIBIAL INSERT SZ 3, 11MM, SLOPE ++ ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH.

  Patient problems: Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20199738 ↗
• InjuryApr 15, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT A 79 YO FEMALE PATIENT, INITIAL LEFT TOTAL KNEE IMPLANTED ON (B)(6) 2013, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 10 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY 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) 2024. THE PATIENT UNDERWENT A FULL KNEE REVISION TO A COMPETITOR¿S PRODUCT. THE POLY SHOWED SOME OXIDATION AND DELAMINATION. THE PATELLA WAS LOOSE AND CAME OFF THE PATELLA BONE. THE FEMORAL COMPONENT WAS LOOSE AND WAS REMOVED FROM THE BONE. THE TIBIA IMPLANT WAS REMOVED FROM THE BONE. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THERE WAS A 30-45 MINUTE SURGICAL DELAY DURING THE PROCEDURE WITH NO ADVERSE EVENTS TO THE PATIENT AS A RESULT. NO X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. THEY WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. N

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

  MAUDE report 19112474 ↗
• InjuryAug 28, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT AN 82 YO MALE PATIENT, WHO HAD BILATERAL KNEE REPLACEMENTS, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2009, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 13 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY AND DISSATISFACTION WITH THEIR TKA¿S. THE LEFT HURT MORE THAN THE RIGHT AT THIS TIME. THE PATIENT UNDERWENT A POLY INSERT AND PATELLA IMPLANT SWAP. THE PATIENT HAD RECALLED POLY IMPLANTS. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IMAGES AND X-RAYS WERE PROVIDED. NO DEVICE RETURN ANTICIPATED. THE IMPLANT WAS SENT TO THE LAB AND LEGAL AT THE HOSPITAL. NO FURTHER INFORMATION KNOWN. RIGHT KNEE REPORTED UNDER 1038671-2023-02062.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17632977 ↗
• InjuryJul 17, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2008 AND APPROXIMATELY 6 YEARS, 4 MONTHS LATER EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2015. IT IS STATED THAT THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS AS A RESULT OF THE DEVICE: JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, POLYETHYLENE WEAR, & CONSTRAINED LINER REVISION. 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.

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

  MAUDE report 17332253 ↗
• InjuryMay 17, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF (B)(6), 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 200-73-11-INSERTO TIBIAL SLOPE++ CR 3-11 MM, SERIAL NUMBER (B)(6) ON (B)(6) 2015. THE INSERT WAS MANUFACTURED ON (B)(6) 2010 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON (B)(6) 2010 AND WAS 4.73 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6) 2021, APPROXIMATELY 6.0 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 16950566 ↗
• InjuryNov 29, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED BY LEGAL, THIS FEMALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2010. SINCE THEN, THE IMPLANT HAS CAUSED HER CONSTANT PAIN AND DISCOMFORT ASSOCIATED WITH THE OPTETRAK DEVICE, INCLUDING, BUT NOT LIMITED TO, POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, AND/OR COMPONENT LOOSENING. SHE REQUESTED THAT HER SURGEON TREAT THE RIGHT KNEE PAIN CAUSED BY HER OPTETRAK DEVICE AND WAS ADVISED THE KNEE REPLACEMENT HAD FAILED AND WOULD REQUIRE REVISION. THE PATIENT HAS EXPERIENCED SO MUCH PAIN AND DISCOMFORT IN HER RIGHT KNEE THAT SHE IS FEARFUL OF OBTAINING A LEFT KNEE REPLACEMENT. THE PATIENT WAS REVISED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 15877680 ↗

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-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-2155-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 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-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-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-