Optetrak 200-07-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862314277), received between Sep 22, 2023 and Jul 15, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 reports).

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

3 other recalls cover devices cleared under the same FDA submission (K160484); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 18, 2024Open, Classified

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

   Z-2158-2024 · Root cause: Under Investigation by firm · FDA record ↗

2. Nov 21, 2023Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL LEFT SIDE TKA, THE MALE PATIENT COMPLAINED OF PAIN. PATIENT HAD LOOSE FEMUR. PATIENT WAS NOT REVISED TO EXACTECH DEVICES DUE TO RECALL SURGEON USED COMPETITOR. THERE WAS NO BREAKAGE OF A DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Pain

  MAUDE report 22506512 ↗
• InjuryFeb 25, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST INITIAL RIGHT SIDE TKA, THE 37 Y/O FEMALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A REVISION DUE TO LOOSE FEMUR, PROSTHETIC WEAR AND RECALLED POLY AND DUE TO RECALL SURGEON USED COMPETITOR'S DEVICE FOR REVISION. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY AND IMAGES RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Pain

  MAUDE report 21459436 ↗
• InjuryFeb 19, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL RIGHT TKA, THIS 73 Y/O FEMALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR AND RECALLED POLY. PATIENT HAD COMPLAINED OF PAIN. DUE TO RECALL SURGEON IS USING COMPETITOR FOR REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. X-RAY & PHOTO ATTACHED. PRODUCT NOT RETURNING. DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 21413190 ↗
• InjuryJan 29, 2025Naturally Worn; Naturally Worn

  LEGAL CASE - USA PATIENT ID: (B)(6), RELATED CASE: (B)(4). 13-AUG-2024 ADDITIONAL INFORMATION: IT IS REPORTED VIA LEGAL DOCUMENTATION THAT PATIENT HAD A REVISED RIGHT TKA (OP REPORTS AND IMPLANT LIST ATTACHED). FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO PREMATURE POLYETHYLENE WEAR FROM A RECALLED POLYETHYLENE INSERT AND FEMORAL LOOSENING. ADDITIONAL INFORMATION RECEIVED ON 23-JAN-2024: 193. ON (B)(6) 2017, PLAINTIFF (B)(6) UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH A NOW-RECALLED TRULIANT DEVICE IN HER RIGHT KNEE AT (B)(6) MEDICAL CENTER IN (B)(6). 196. IN OR ABOUT SUMMER 2023, PLAINTIFF (B)(6) BEGAN EXPERIENCING SIGNIFICANT PAIN AND SWELLING IN HER KNEES. PLAINTIFF ALSO BEGAN EXPERIENCING LOCKING OF THE KNEES AND MOBILITY IMPAIRMENT. 197. IN APPROXIMATELY (B)(6) 2023, PLAINTIFF VISITED HER ORTHOPEDIC PROVIDER AND REPORTED THESE SYMPTOMS. HER PROVIDER EXPLAINED THAT DUE TO THE DEFECTIVE TRULIANT DEVICES, DEBRIS WOULD NEED TO BE CLEANED OUT OF THE SURROUNDING TISSUE, AND REVISION SURGERY TO BOTH KNEES WOULD BE REQUIRED. 201. SUBSEQUENTLY, DUE TO CONTINUED AND WORSENING PAIN, SWELLING, INSTABILITY, AND ¿FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO PR

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Emotional Changes; Implant Pain; Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 21267439 ↗
• InjuryDec 31, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 38 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS INCREASED SWELLING, PAIN, INSTABILITY AND PROSTHESIS WEAR/LOOSENING. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE FINDINGS NOTED FAILED LEFT TOTAL KNEE SECONDARY TO POLYETHYLENE WEAR AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. INTRAOPERATIVELY, THE SURGEON OBSERVED NO SIGNS OF INFECTION OR PURULENCE. SYNOVITIS, SCAR TISSUE AND EARLY WEAR OF THE PATELLAR BUTTON AND A LOOSE FEMORAL COMPONENT WERE NOTED. THESE COMPONENTS WERE REMOVED WITH MINIMAL BONE LOSS. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21046936 ↗
• InjuryOct 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 4 YEARS AND 3 MONTHS POST THE INITIAL LEFT TKA, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO A RECALLED PATELLA. THE PATIENT WAS REVISED TO COMPETITOR DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 20403670 ↗
• InjurySep 9, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA CASE (B)(4). LK IS ASSOCIATED WITH THIS CASE. 9/6/24: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 9/3. ATTACHED EMAIL AND REVISION OP REPORT. ADDED PATELLA DEVICE INFORMATION AND ANNEX E CODES BASED ON NEW INFORMATION RECEIVED. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO PREMATURE POLYETHYLENE WEAR FROM A RECALLED TIBIAL INSERT AND PATELLAR INSERT. DESCRIPTION OF PROCEDURE: THERE WAS EVIDENCE OF POLYETHYLENE SYNOVITIS WITH PARTICULATE DEBRIS IN THE GUTTERS. I EVERTED THE PATELLA AND REMOVED THE SCAR TISSUE FROM AROUND THE EDGES. THERE WAS SOME EARLY FLATTENING OF THE LATERAL FACET CONSISTENT WITH THE POLYETHYLENE WEAR. I THEREFORE DECIDED TO EXCHANGE IT. I USED A THIN SAGITTAL SAW AND WAS ABLE TO REMOVE THIS WITHOUT ANY ADDITIONAL BONE LOSS. I FLEXED THE KNEE UP AND REMOVED THE PREVIOUS TIBIAL INSERT USING A 0.5-INCH OSTEOTOME. ON GROSS INSPECTION, THERE WERE NO OBVIOUS SIGNS OF WEAR. I USED THE OFFSET OSTEOTOME AND A 0.25-INCH OSTEOTOME TO BREAK UP THE CEMENT MANTLE. I WAS THEN ABLE TO DISIMPACTION THE FEMORAL COMPONENT WITH MINIMAL BONE LOSS. I EXPOSED THE TIBIA. I USED AN OFFSET OSTEOTOME, A 0.25-INCH AND

  Patient problems: Failure of Implant; Implant Pain; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20168005 ↗
• InjuryAug 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 46 MONTHS AFTER A LEFT KNEE 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20048407 ↗
• InjuryAug 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3 YEARS AND 10 MONTHS POST THE PREVIOUS LEFT REVISION, THE PATIENT WAS REVISED AGAIN BECAUSE THE PATELLA FELL OUT AND HAD TO BE BONE GRAFTED DUE TO OSTEOLYSIS OF THE PATELLA. THE PATIENT WILL REQUIRE AN ADDITIONAL SURGERY TO REPAIR THE PATELLA ONCE THE BONE GRAFT HAS GROWN NEW BONE. 30CC OF BONE GRAFT WAS USED TO GRAFT THE PATIENT'S PATELLA. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 19946022 ↗
• InjuryJun 19, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT EXPERIENCED A RIGHT KNEE SURGICAL PROCEDURE APPROXIMATELY 2 YEARS 2 MONTHS POST INITIAL IMPLANT. PREOPERATIVE DIAGNOSES: FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO PREMATURE POLYETHYLENE WEAR FROM A RECALLED POLYETHYLENE INSERT AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. REVISION RIGHT. TOTAL KNEE ARTHROPLASTY OF FEMORAL, TIBIAL, AND PATELLAR COMPONENTS. PATIENT WAS REVISED TO COMPETITOR'S IMPLANTS. INFECTION WORK-UP WAS NEGATIVE. THERE WAS SOME EARLY POLYETHYLENE SYNOVITIS, BUT NO SIGNS OF INFECTION OR PURULENCE. THERE WAS EARLY WEAR OF THE PATELLAR BUTTON ON THE LATERAL FACET WITH FLATTENING, IT WAS EXCHANGED. ON GROSS INSPECTION OF THE TIBIAL INSERT, THERE WERE NO OBVIOUS SIGNS OF SIGNIFICANT WEAR, THERE WERE A COUPLE OF AREAS OF SOME PINNING. THERE WAS FAILURE OF BONY INGROWTH FOR THE FEMORAL COMPONENT, IT WAS REMOVED. TIBIAL COMPONENT WAS REMOVED. TILE PATIENT WAS AWOKEN FROM ANESTHESIA AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS. DEVICE WILL NOT BE RETURNED. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Emotional Changes; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 19567639 ↗
• InjuryMay 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 52 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE. THE PATIENT EXPERIENCED PROSTHESIS WEAR AND PAIN. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19361197 ↗
• InjurySep 22, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON 29 APR 2022. 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. THE PATIENT HAS FILED A COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. 2022 CA 002670. 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 RES

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity

  MAUDE report 17801508 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160484. 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-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