Truliant 02-022-35-5009Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10885862304612), received between Sep 20, 2021 and Apr 17, 2025 — classified as 1 death, 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (17 reports).

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

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-0023-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 2 YEARS POST INITIAL OPERATION. THE PATIENT HAD A POLY EXCHANGE DUE TO INSTABILITY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Laxity

  MAUDE report 21859679 ↗
• InjuryJan 27, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4), PATIENT ID: (B)(6), RELATED (B)(4). ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 25-SEP-2023- 9 JAN 2024, (B)(6), RN- IMPLANT DATE: ON (B)(6) 2021, FOR OSTEOARTHRITIS, MORBID OBESITY/ BMI 46 (OP REPORT ATTACHED), EXPLANT DATE: ON (B)(6) 2022, POST OPERATIVE DIAGNOSIS: FAILED LEFT KNEE, SECONDARY TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND RECALLED TIBIAL INSERT. PATIENT TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION. (OP REPORT ATTACHED). THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(4). ORIGINAL DESCRIPTION SUMMARY: ADDITIONAL INFORMATION: LEGAL SHORT FORM RECEIVED FROM LEGAL ON 20-JUN-2023 LEGAL CASE (B)(6). IMPLANT DATE: ON (B)(6) 2019 EXPLANT DATE: ON (B)(6) 2023 NO FURTHER INFORMATION. ORIGINAL DESCRIPTION SUMMARY: EXPERIENCE REPORT - USA. AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL LEFT TKA, THIS 69 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR. PATIENT COMPLAINED OF PAIN. DUE TO RECALL SURGEON USED COMPETITORS IMPLANTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IS THE REPORTED EVENT ASSOCIATED WITH REVISION OF EXACT

  Patient problems: Joint Laxity; Joint effusion; Pain; Scar Tissue; Synovitis

  MAUDE report 21246921 ↗
• InjuryJan 10, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL RIGHT TKA, THIS 90 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR. PATIENT COMPLAINED OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL PATIENT INFORMATION REPORTED. DEVICES NOT RETURNING, HOSPITAL WILL NOT RELEASE.

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

  MAUDE report 21124625 ↗
• InjuryDec 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 34 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS SIGNIFICANT KNEE PAIN, SWELLING, AND DYSFUNCTION AFTER A 2ND FALL. HE PRESENTED TO AN OUTSIDE ER AND AN ASPIRATION WAS PERFORMED. THE WAS ALSO ASPIRATED A 2ND TIME, WHERE PURULENCE WAS IDENTIFIED AND CULTURES WERE OBTAINED, INDICATING LEFT KNEE PERIPROSTHETIC INFECTION. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. INTRAOPERATIVE FINDINGS INDICATED NO GROSS PURULENCE. THE SURGEON PERFORMED A KNEE INCISION, IRRIGATION AND DEBRIDEMENT, NEAR TOTAL SYNOVECTOMY, AND POLYETHYLENE LINER EXCHANGE. THE PATIENT WAS AWOKEN IN THE OPERATING ROOM AND IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Medical device site infection; Pain; Swelling/ Edema

  MAUDE report 20825330 ↗
• InjurySep 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 55 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, IMMENSE PAIN, LOSS OF MOBILITY, REVISION SURGERY, AND LOSS OF CONSORTIUM. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20235653 ↗
• InjurySep 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY UNKNOWN MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20136910 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 61 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED IN (B)(6) 2022, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 2 YEARS 6 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. INTERSEP BEADS AND INTERSPACED WAS USED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE REP WAS UNABLE TO OBTAIN X-RAYS. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS DUE TO THE HOSPITAL¿S CHAIN OF COMMAND POLICY DUE TO THE RECALL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 19906680 ↗
• InjuryJun 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 48 MONTHS AFTER AN ARTHROSCOPIC IRRIGATION AND DEBRIDEMENT OF LEFT SEPTIC KNEE ARTHROPLASTY WITH NEAR TOTAL SYNOVECTOMY AND EXCHANGE OF HIS POLYETHYLENE LINER, THE PATIENT WENT ON TO DEMONSTRATE A PERSISTENT INFECTION IN HIS KNEE. IT WAS ELECTED BY PATIENT AND DOCTOR TO DO A COMPLETE EXPLANT, ANTIBIOTIC SPACER, IV ANTIBIOTICS AND A 2-STAGE REVISION KNEE ARTHROPLASTY. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. INTRAOPERATIVELY, THE SURGEON OBSERVED PURULENT FLUID, SYNOVECTOMY WAS PERFORMED, THOROUGH IRRIGATION AND DEBRIDEMENT WAS COMPLETED. NO MEDICAL OR SURGICAL INTERVENTION WAS NOTED. APPROXIMATELY 3 MONTHS AFTER STAGE ONE SURGERY WAS COMPLETED, THE PATIENT UNDERWENT STAGE TWO PROCEDURE OF ANTIBIOTIC SPACER EXPLANT AND TOTAL KNEE ARTHROPLASTY. SURGICAL NOTES WERE PROVIDED, IT WAS NOTED THAT DURING THE PROCEDURE, ANTIBIOTIC SPACER WAS REMOVED TAKING CARE TO PRESERVE AS MUCH BONE AS POSSIBLE. A COMPLETE REVISION KNEE ARTHROPLASTY WAS THEN PLACED. FROZEN SECTION WAS NEGATIVE FOR NEUTROPHILS. PREOPERATIVE LABORATORY STUDIES WERE ALSO REVIEWED WHERE CBC, ESR AND CRP WERE WITHIN NORMAL LIMITS. AT THE COMPLETION OF PROCEDURE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint effusion; Medical device site infection; Unspecified Infection

  MAUDE report 19454824 ↗
• InjuryMar 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 4 YEARS AND 11 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 18951500 ↗
• InjuryDec 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REVISION SURGERY ON (B)(3)THEY UNDERWENT A SECOND RIGHT KNEE REVISION SURGERY (B)(3) 2021, APPROXIMATELY 12 YEARS 6 MONTHS AFTER THEIR FIRST REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. 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. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint effusion; Pain; Synovitis

  MAUDE report 18276514 ↗
• MalfunctionNov 15, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  AS REPORTED, PRIOR TO USE/DURING SET-UP, THE STAFF OPENED THE PACKAGE FOR A SIZE 5X9MM PS POLY AND THERE WAS A 3.5X9MM PS POLY INSIDE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE EVENT IS NOT PATIENT RELATED. THE DEVICE WILL BE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145083 ↗
• InjuryNov 12, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST INITIAL RIGHT TKA, UPON REMOVAL OF THE TIBIAL LINER INSERT, THE SURGEONS NOTICED THAT THERE WAS SOME BACK POLY WEAR. ALSO, THE SURGEON REMOVED ALL; THERE IS A STEEL LYSIS ON THE LATERAL SIDE WITH A SIGNIFICANT AMOUNT OF BONE LOST POSTERIORLY. THE PATIENT WAS REVISED TO A CONSTRAINED RIGHT SIZE 5 FEMUR WITH A 10 MM AUGMENT LATERAL POSTERIORLY WITH AN 18 X 120 STEM, H32 MEDIUM CONE IN A 2° COUPLER. SIZE 15 MM CONSTRAINED LINER. 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.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 18117460 ↗
• InjuryOct 3, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THIS DEVICE HAS NOT BEEN EXPLANTED. THE PATIENT EXPERIENCES JOINT PAIN, JOINT SWELLING AND STIFFNESS. 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 SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS: ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

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

  MAUDE report 17860774 ↗
• DeathJul 26, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6), 2021. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6), 2022, APPROXIMATELY 1 YEAR LATER. THE PATIENT CLAIMS TO HAVE SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS AS A RESULT OF THIS EXACTECH DEVICE: CONSTANT SWELLING, INTENSE PAIN AND HAD TO UNDERGO A TOTAL KNEE REVISION ARTHROPLASTY. 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: Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 17399136 ↗
• InjuryJul 18, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6), 2018. APPROXIMATELY 4 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6), 2023. THE PATIENT HAS SUFFERED SEVERE PAIN AND LOSS OF MOBILITY. 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; Insufficient Information; Pain

  MAUDE report 17344658 ↗
• InjuryJun 16, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6) 2018. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2021, APPROXIMATELY 2 YEARS 6 MONTHS AFTER THEIR INITIAL PROCEDURE. PREOPERATIVE X-RAYS SHOWED STABLE COMPONENTS, BUT BONE SCAN LIGHT UP ON THE FEMUR. REVISION OPERATIVE REPORT ON (B)(6) 2021. REVISION RIGHT TOTAL KNEE ARTHROPLASTY. POSTOPERATIVE DIAGNOSIS: FILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC FEMORAL LOOSENING. THE PATELLA WAS FOUND TO BE WELL FIXED. THE FEMUR WAS ABLE TO BE DISIMPACTED FROM THE CEMENT WITHOUT ANY ADHERENCE TO THE CEMENT. CEMENT WAS MANTLE WAS PRISTINE AND INTACT ON THE FEMUR. TIBIA WAS WELL FIXED. 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: Failure of Implant

  MAUDE report 17146727 ↗
• InjuryMay 26, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A 60 Y/O MALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 2 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 DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT (B)(6) 2023. DIAGNOSIS: FAILED LEFT KNEE SECONDARY TO EARLY POLYETHYLENE WEAR AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENET. SIGNIFICANT SCAR TISSUE AND SYNOVITIS SEEN. PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Scar Tissue; Synovitis

  MAUDE report 17010602 ↗
• InjuryMay 19, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2021. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS AS A RESULT OF THIS EXACTECH DEVICE: SWELLING, LOOSENESS, AND KNOCKING. IT IS ALSO STATED THAT THE PATIENT HAS A REVISION SCHEDULED, THERE IS NO INFORMATION PROVIDED THAT A REVISION HAS OCCURRED. 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; Discomfort; Failure of Implant; Inflammation; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16968277 ↗
• InjuryApr 27, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT IS VERIFIED TO HAVE HAD BILATERAL KNEE ARTHROPLASTY ON (B)(6) 2018 (LEFT) & (B)(6) 2018 (RIGHT). HE HAD RIGHT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 4 YEARS 4 MONTHS AFTER THEIR INITIAL IMPLANTATION, DUE TO POLYETHYLENE WEAR AND POTENTIAL LYSIS. THERE WAS ALSO ISSUES WITH FEMORAL LOOSENING WITH HIS IMPLANT. POSTOP DIAGNOSIS: FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR FROM A RECALLED INSERT AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THE PATIENT'S SURGEON NOTED THAT "THERE WAS SIGNIFICANT WEAR ALONG THE MEDIAL AND LATERAL FACETS" OF THE PATELLAR BUTTON. UPON GROSS INSPECTION OF THE TIBIAL INSERT, THERE WERE NO OBVIOUS SIGNS OF SIGNIFICANT POLYETHYLENE WEAR. THERE WAS SOME PITTING ON THE ARTICULAR SURFACES. THE FEMORAL COMPONENT WAS NOTED TO HAVE "NO ATTACHMENT AND IT WAS LOOSE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 16827497 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST INITIAL LEFT SIDE TKA, THE 54 Y/O MALE PATIENT COMPLAINED OF PAIN. PATIENT DUE TO RECALL SURGEON USED COMPETITORS IMPLANTS FOR REVISION. THERE WAS NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. IMAGE RECEIVED. SALES REP WAS UNABLE TO OBTAIN. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Pain

  MAUDE report 16264445 ↗
• InjuryOct 10, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON MAY 14, 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022 APPROXIMATELY 2 YEARS 3 MONTHS POST THE INITIAL PROCEDURE AS THE PATIENT PRESENTED WITH INSTABILITY AND OSTEOLYSIS. THE SURGEON REVISED TO A SIZE 4 RIGHT CONDYLAR CONSTRAINED FEMUR WITH A 4/5MM DISTAL AUG LARGE 32 CONE AND 20X120 STEM. 4F/3T FIT TRAY WITH 32 CONE AND 16X80 STEM. 4/15MM CC INSERT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE IS RETURNING DUE TO THE PATIENT¿S LAWYER.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 15572474 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FIFTEEN MONTHS POST INITIAL LEFT TKA, THE 72 Y/O MALE PATIENT HAD A POLY INSERT EXCHANGE. THIS IS THE THIRD SURGERY WITH EXACTECH. PATIENT HAD A PRIMARY KNEE DONE ON (B)(6) 2019. THEN A EXACTECH FEMORAL REVISION ON (B)(6) 2021. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS OR X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE THE IMPLANTS.

  Patient problems: Discomfort; Failure of Implant; Joint effusion; Osteolysis; Pain

  MAUDE report 14838870 ↗
• InjurySep 20, 2021Misassembled; Device Dislodged or Dislocated; Misassembled; Device Dislodged or Dislocated

  APPROXIMATELY 4 YEARS POSTOP THE INITIAL LTSA, A SURGEON ¿INHERITED¿ THIS (B)(6) Y/O MALE PATIENT AND DETERMINED TO COMPLETE A REVISION. THE LINER WAS DISASSOCIATED FROM THE TIBIAL TRAY. ON FURTHER INSPECTION THE FEELING WAS IT WAS NOT CORRECTLY LOCKED INTO THE POSTERIOR OF THE TRAY AND WAS FORCED IMPACTED IN. THE SURGEON WENT FROM A SIZE 5/9MM PS TO A SIZE 5/15MM PS INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12503003 ↗