Optetrak 200-07-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10885862314284), received between Jun 8, 2022 and Aug 27, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Naturally Worn” (20 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Naturally Worn

  Report #3 of 3 for this event.It was reported this patient underwent bilateral total knee arthroplasties. Subsequently four (4) years, eight (8) months later, the patient experienced pain and lysis of the right knee. As a result, the patient underwent a right knee revision procedure due to polyethylene wear and lysis secondary to a recalled polyethylene insert and femoral loosening. An operative report was provided. Intraoperatively, synovitis was observed. The patella was significantly damaged, linear wear markings on the articular surface of the tibial insert and the femoral was removed cleanly with no attachment. The patient was awoken from anesthesia and transferred to the recovery room in stable condition.Additionally, it is reported via legal documentation this patient alleges experiencing significant pain and discomfort, stiffness, gait impairment, difficulty walking, difficulty ascending and descending stairs, inflammation, swelling and other injuries presently undiagnosed.

  Patient problems: Ambulation or Postural Difficulties; Osteolysis; Pain; Synovitis

  MAUDE report 50484727 ↗
• InjuryMay 12, 2026Naturally Worn

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY AND OPERATIVE NOTES, THE PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT SURGERY. THE PATIENT HAD INITIALLY DONE WELL BUT STARTED HAVING INCREASED PAIN AND SWELLING. AN INFECTION WORKUP WAS NEGATIVE. APPROXIMATELY 4 YEARS AND 4 MONTHS POST THE INITIAL SURGERY; THE PATIENT¿S RIGHT KNEE WAS REVISED TO NON-EXACTECH COMPONENTS DUE TO SUSPECTED POLYETHYLENE WEAR AND FEMORAL COMPONENT LOOSENING. PER THE OPERATIVE NOTES, THERE WAS A TYPICAL SYNOVITIS WITH PARTICULATE DEBRIS AND THE SYNOVIAL TISSUE IN THE MEDIAL AND LATERAL GUTTERS. THERE WAS BROWNISH DISCOLORATION AS WELL AND LOOKED GRITTY. SURGEON DEBRIDED THIS SYNOVIAL TISSUE AND SENT A SAMPLE OF THE TISSUE FOR CULTURE. THERE WERE NO SIGNS OF PURULENCE OR INFECTION. ON GROSS INSPECTION, THERE WAS NO SIGNIFICANT WEAR (TO THE TIBIAL INSERT). THERE WERE SOME PITTING CHANGES IN THE ARTICULAR SURFACE, PRIMARILY MEDIALLY AND THE FEMORAL COMPONENT WAS DISIMPACTED WITHOUT ANY DIFFICULTIES AS THERE WAS NO ATTACHMENT TO THE CEMENT MANTLE. ADDITIONALLY, THERE WAS GROSS DAMAGE TO THE PATELLAR BUTTON. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CO

  Patient problems: Aseptic loosening; Pain; Swelling/ Edema; Synovitis

  MAUDE report 25150520 ↗
• InjuryFeb 13, 2026Unstable; Migration

  IT WAS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY THAT THIS FEMALE PATIENT WAS EXPERIENCING PATELLAR INSTABILITY AND WAS PRESCRIBED A BRACE TO BE WORN DAILY. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. OUTCOME IS CONTINUING. NO OTHER INFORMATION IS FORTH COMING.

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 24333785 ↗
• InjuryDec 22, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND FEMORAL LOOSENING. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION 5 YEARS AND 11 MONTHS AFTER INITIAL IMPLANTATION. PROVIDED IMAGES OF THE TIBIAL INSERT OF WEAR. PROVIDED IMAGES OF THE PATELLAR COMPONENT SHOW SIGNS OF WEAR AND FRACTURE. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE. THIS IS REPORT 3 OF 3 FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 23867074 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND DISCOMFORT IN THE KNEE, AND AVASCULAR NECROSIS OF THE PATELLA WAS IDENTIFIED APPROXIMATELY 1 YEAR AND 6 MONTHS LATER. NO MEDICAL OR SURGICAL INTERVENTION IS PLANNED AT THIS TIME. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Necrosis; Pain

  MAUDE report 22797771 ↗
• InjuryMay 27, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 9 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO A LOOSE FEMUR AND BAD POLY. 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. ADDITIONAL INFORMATION RECEIVED VIA LEGAL NOTIFICATION NOTED THAT THE PATIENT UNDERWENT THE REVISION PROCEDURE TO ADDRESS WEAR, LOOSENING, PAIN, STIFFNESS, SWELLING, DISCOMFORT, WEAKNESS, AND INSTABILITY.

  Patient problems: Aseptic loosening; Discomfort; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 22087853 ↗
• InjuryMar 19, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL LEFT TKA, THE 55 Y/O MALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A REVISION DUE TO LOOSE FEMUR AND RECALLED POLY. DUE TO RECALL SURGEON USED COMPETITOR'S DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. EBI INITIAL SURGERY & QAD SERIAL TRACE ATTACHED. (B)(6), 02-022-35-3509 - TRULIANT TIB IMP PS INSERT SZ 3.5 9MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K152170.

  Patient problems: Pain

  MAUDE report 21646647 ↗
• InjuryMar 14, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 6 YEARS AND 2 MONTHS POST INITIAL PROCEDURE. PATIENT COMPLAINED OF PAIN AND HAD A RECALLED POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 21606019 ↗
• InjuryMar 11, 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 AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. APPROXIMATELY 6-9 MONTHS PRIOR TO REVISION, THE PATIENT BEGAN EXPERIENCING INCREASED STIFFNESS, PAIN, AND SWELLING. RADIOGRAPHS SHOWED POSSIBLE RADIOLUCENCY AT THE END OF THE FEMORAL COMPONENT, BUT OTHERWISE NO GROSS OBVIOUS SIGNS OF WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. FINDINGS ALSO INDICATED SIGNIFICANT SCAR TISSUE, DAMAGE ON THE LATERAL FACET OF THE PATELLA, SIGNIFICANT YELLOW COLORATION OF THE MEDIAL ARTICULAR SURFACE OF THE POLYETHYLENE WITH SOME BRITTLENESS, AND AN OSTEOLYTIC CYST ON THE MEDIAL CONDYLE OF THE FEMUR. THE SURGEON PERFORMED A REVISION LEFT TOTAL KNEE ARTHROPLASTY OF FEMORAL, TIBIAL, AND PATELLAR COMPONENTS. 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; Cyst(s); Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 21576571 ↗
• InjuryMar 7, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 75 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PREMATURE POLYETHYLENE WEAR FROM RECALLED POLYETHYLENE INSERT, ASEPTIC LOOSENING OF FEMORAL AND PATELLAR COMPONENTS. 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: Joint Laxity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 21552173 ↗
• InjuryFeb 25, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 54 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DISCOMFORT, PAIN, JOINT LAXITY, SCAR TISSUE, SWELLING/EDEMA, AND SYNOVITIS. 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: Discomfort; Implant Pain; Joint Laxity; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 21460328 ↗
• InjuryJan 16, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 89 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FEMORAL LOOSENING, FAILURE OF IMPLANT, AND PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21173522 ↗
• InjuryDec 27, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2018. THE PATIENT CLAIMS THEY MAY NEED REVISION SURGERY; NO SCHEDULED SURGERY HAS BEEN REPORTED. 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: Failure of Implant; Joint effusion; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 21026750 ↗
• InjuryDec 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 54 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, INSTABILITY, SYNOVITIS, JOINT LAXITY, SCAR TISSUE, FAILURE OF IMPLANT, SWELLING/EDEMA, 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: Failure of Implant; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20925995 ↗
• InjuryDec 3, 2024Patient-Device Incompatibility; Naturally Worn; Patient-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 5 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT LEFT KNEE ARTHROSCOPY. NO ADDITIONAL INFORMATION WAS RECEIVED. NO OP NOTES OR X-RAYS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Pain

  MAUDE report 20835690 ↗
• InjuryNov 26, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE APPROXIMATELY 60 MONTHS AFTER INITIAL IMPLANT. PREMATURE POLY WEAR AND ASEPTIC FEMORAL LOOSENING. 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: Implant Pain; Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 20780867 ↗
• InjuryNov 21, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE - USA IT WAS REPORTED THAT APPROXIMATELY 67 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, INSTABILITY, MILD SWELLING AND CHRONIC EFFUSION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. PATIENT ID: (B)(6), SURGERY/INVOICE DATE: ON (B)(6) 2018, DATE OF INSERT MANUFACTURE: 2018-01-03, SHELF-LIFE AT TIME OF IMPLEMENTATION: 0 - 1, ITEM NUMBER AND FULL CORPORATE DESCRIPTION: 02-022-51-4012 - TRULIANT TIB IMP CRC INSERT SZ 4, 12MM, SERIAL NUMBER: (B)(6), INSERT THICKNESS: 12. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. NO FURTHER INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Joint effusion; Swelling/ Edema; Synovitis

  MAUDE report 20750896 ↗
• InjuryNov 1, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA. ORIGINAL DESCRIPTION SUMMARY: AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT. APPROXIMATELY 2 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2020. 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 DETERMINE RIGHT AND LEFT PRODUCTS. THE PATIENT HAS FILED A COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(6). 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

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20587391 ↗
• InjuryOct 28, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ (B)(6). PATIENT ID: (B)(6) + RIGHT KNEE. 7/24/24: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 7/24/24. ATTACHED EMAIL AND REVISION OP REPORT. INDICATIONS FOR THE PROCEDURE: THIS IS A 56-YEAR-OLD FEMALE WHO HAD A RIGHT TOTAL KNEE ARTHROPLASTY. SHE DID WELL UNTIL ABOUT 4.5 YEARS POST TKA WHEN SHE STARTED HAVING INCREASING PAIN AND SWELLING IN THE KNEE. INFECTION WORKUP WAS NEGATIVE. SHE FAILED CONSERVATIVE MANAGEMENT INCLUDING ANTI-INFLAMMATORIES, PHYSICAL THERAPY, GAIT ASSISTANCE AND ACTIVITY MODIFICATION. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED A FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO PREMATURE POLYETHYLENE WEAR FROM A RECALLED POLYETHYLENE INSERT AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. DESCRIPTION OF PROCEDURE: THERE WAS POLYETHYLENE SYNOVITIS IN THE SUPERIOR ASPECT OF THE KNEE. I DID DEBRIDEMENT OF THE SYNOVIAL TISSUE WITH THE POLYETHYLENE DEBRIS AND SENT A SAMPLE OF THIS FOR CULTURE. THERE WERE NO SIGNS OF INFECTION OR PURULENCE. I CLEARED OFF THE SCAR TISSUE FROM AROUND THE PATELLAR BUTTON. THERE WAS FLATTENING AND WEAR OF THE LATERAL FACET AS WELLS AS A GOUGE OUT OF THE MEDIAL SIDE. I THEREFORE DECIDED TO EXCHANGE IT. I USED A THIN S

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

  MAUDE report 20546833 ↗
• InjuryOct 21, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2 YEARS AND 2 MONTHS POST INITIAL LEFT TOTAL KNEE ARTHROPLASTY (TKA), A REVISION WAS PERFORMED DUE TO COMPLAINT OF PAIN. FOR THE REVISION, INTERSEP AND AN INTERSPACE WERE USED. THERE WAS NO REPORTED BREAKAGE OF THE DEVICE AND NO SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 20497017 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL LEFT TKA, THE 48 Y/O FEMALE PATIENT COMPLAINED OF PAIN. THE PATIENT HAD A REVISION DUE TO LOOSE FEMUR AND RECALLED POLY. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Joint effusion; Osteolysis; Pain

  MAUDE report 20064123 ↗
• InjuryMay 21, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 10 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ASEPTIC LOOSENING OF THE PATELLAR COMPONENT AND FLEXION INSTABILITY FOLLOWING A FALL. 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: Failure of Implant; Implant Pain; Joint Laxity; Synovitis

  MAUDE report 19358543 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT ON (B)(6) 2022 THE PATIENT WAS REVISED AND THEN APPROXIMATELY 7 MONTHS LATER THE PATENT EXPERIENCED A SURGICAL PROCEDURE WITH DEVICE EXCHANGE ON (B)(6) 2023. REVISION OP REPORT OF (B)(6) 2023- POSTOPERATIVE DIAGNOSIS- PATELLAR RUPTURE FROM THE PATELLA. PROCEDURE 1. REVISION, TOTAL KNEE 2. REPAIR OF PATELLAR TENDON WITH GRAFT TECHNIQUE. PATIENT WITH PAIN AND DISCOMFORT OF HER KNEE, LOSS OF EXTENSION. IT WAS NOTED THAT THE PATELLAR TENDON ¿WAS FREED FROM THE DISTAL POLE OF THE PATELLA AND NOT FUNCTIONING¿. REVISION OF FEMUR, ALTHOUGH IT WAS NOT LOOSE. GRAFTS FOR PATELLA TENDON WERE PUT IN PLACE. A LONG LEG CAST WAS APPLIED WITH KNEE COMPLETE EXTENSION. THE PATIENT WAS TAKEN TO RECOVERY ROOM IN GOOD 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: Discomfort; Muscle/Tendon Damage; Pain; Rupture

  MAUDE report 19020794 ↗
• InjurySep 5, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL RIGHT TKA, THE 69 Y/O MALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A REVISION DUE TO LOOSE FEMUR AND RECALLED POLY. DUE TO RECALL SURGEON USED COMPETITOR DEVICE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND IMAGES OBTAINED AND RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE HOSPITAL DO NOT RELEASE RECALL DEVICES.

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

  MAUDE report 17686679 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDIES, EXACTECH TRULIANT KNEE CLINICAL STUDY, THAT A 53 YO FEMALE PATIENT, HEIGHT: 68 IN, WEIGHT: 168 LBS, WHO HAD INITIAL IMPLANT SURGERY ON HER RIGHT KNEE ON (B)(6) 2019 FOR THE PRIMARY INDICATION OF OSTEOARTHRITIS, WAS SEEN APPROXIMATELY 6 MONTHS POST THE INITIAL PROCEDURE. PATELLAR CLUNK SYNDROME INDICATED. ACTION TAKEN, DIAGNOSTIC AND OPERATIVE ARTHROSCOPY OF THE RIGHT KNEE WITH LIMITED SYNOVECTOMY. RELATED TO DEVICE OR PROCEDURE IS UNKNOWN. THE STUDY INDICATES OUTCOME RESOLVED ON (B)(6) 2020.

  Patient problems: Scar Tissue

  MAUDE report 15259089 ↗

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