Optetrak 204-23-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862048332), received between Nov 12, 2020 and Oct 17, 2024 — classified as 9 injuries.

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

1 FDA recall record name this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (K933610); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. (B)(4) 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. HUMPHREYS' 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) MEDICAL CENTER AT (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 20476874 ↗
• InjuryJul 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 117 MONTHS AFTER A RIGHT TOTAL 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; Insufficient Information; Osteolysis; Pain

  MAUDE report 19770440 ↗
• InjuryJun 7, 2024Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 132 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SUFFERED RECURRING PAIN IN HIS LEFT KNEE, CREPITUS SENSATIONS, WEAKNESS, SWELLING, PAIN WHILE AMBULATING, SOFT TISSUE DISCOMFORT, DECREASED RANGE OF MOTION, INSTABILITY, AND DIFFICULTY ARISING FROM A SITTING TO STANDING POSITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19485070 ↗
• InjuryApr 7, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  LEGAL CASE - (B)(6). AS REPORTED VIA THE LEGAL DEPARTMENT, ON (B(6) 2014, THE PATIENT HAD A REVISION OF A TOTAL KNEE REPLACEMENT SURGERY ON THE RIGHT SIDE WAS PERFORMED ON THE PATIENT USING EXACTECH COMPONENTS. OVER THE COURSE OF TIME AFTER THIS SURGICAL PROCEDURE, THE PATIENT EXPERIENCED PAIN AND DISCOMFORT IN HER RIGHT KNEE, FOLLOWING UP WITH THEIR DOCTOR ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT'S DOCTOR RECOMMENDED A RE-REVISION OF THE RIGHT KNEE REPLACEMENT. THE PATIENT IS SCHEDULED TO UNDERGO A RE-REVISION OF THE RIGHT KNEE REPLACEMENT ON (B)(6) 2023 APPROXIMATELY 8 YEARS AND 6 MONTHS AFTER THEIR FIRST REVISION USING EXACTECH COMPONENTS. THERE IS NO INDICATION THAT THE INITIAL IMPLANT USED EXACTECH DEVICES. 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. UNABLE TO LOCATE INITIAL SURGERY IN EBI.

  Patient problems: Discomfort; Emotional Changes; Implant Pain; Joint effusion; Osteolysis; Rheumatoid Arthritis

  MAUDE report 16702200 ↗
• InjuryMar 29, 2023Material Integrity Problem; Naturally Worn; Material Integrity Problem; Naturally Worn

  IT WAS REPORTED FROM THE LEGAL DEPARTMENT THAT ON (B)(6) 2018, A PATIENT UNDERWENT A SECOND REVISION OF THE LEFT EXACTECH KNEE DEVICE SECONDARY TO POLYETHYLENE LINER WEAR, APPROXIMATELY 6 YEARS 4 MONTHS AFTER THE FIRST REVISION. IT IS STATED THAT DESPITE UNDERGOING THE REVISION SURGERIES, THE PATIENT EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS QUALITY OF LIFE. 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: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Emotional Changes; Joint Laxity; Metal Related Pathology; Pain; Unspecified Infection

  MAUDE report 16640217 ↗
• InjuryNov 4, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A FEMALE PATIENT, RIGHT KNEE IMPLANTED ON (B)(6) 2008, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016, APPROXIMATELY 7 YEARS 11 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR REASONS UNKNOWN. NO FURTHER INFORMATION KNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Muscle Weakness/Atrophy; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15725959 ↗
• InjuryOct 18, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, INITIAL KNEE IMPLANTED ON (B)(6) 2007, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 5 YEARS 2 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR POLY WEAR. NO FURTHER INFORMATION REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15628564 ↗
• InjuryOct 12, 2021Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YRS POSTOP THE INITIAL RTKA, THE (B)(6) Y/O MALE PATIENT PRESENTED WITH A ¿SORE KNEE¿, THE INSITU PATELLA WAS WORN AND A PE EXCHANGE WAS PERFORMED DUE TO WEAR AND THE PS CAM AND THE BUTTON ON THE UNDERSIDE OF THE INSERT HAD SNAPPED OFF FROM THE BODY OF THE INSERT AND WAS FLOATING AROUND THE KNEE. THE POLY AFTER THREE YEARS WAS DELAMINATED AND PITTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12617327 ↗
• InjuryNov 12, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2014, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2009. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10833464 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933610. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-
• Z-2070-2012 · Sep 23, 2011 · Terminated
  Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 2
• Z-0347-05 · Nov 11, 2004 · Terminated
  Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.