Truliant 02-022-35-2509Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10885862304162), received between Oct 12, 2022 and Mar 6, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL RIGHT TKA, THIS 52 Y/O FEMALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR. PATIENT COMPLAINED OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 24533511 ↗
• InjuryJan 23, 2025Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 06-NOV-2023: LEGAL CASE ¿ USA. PATIENT ID: (B)(6). REVISION OP REPORT INDICATIONS FOR PROCEDURE: PATIENT HAD RADIOGRAPHIC EVIDENCE OF LOOSENING. DURING SURGERY: THE FEMUR WAS NOTED TO BE QUITE LOOSE AND EASILY REMOVED. ORIGINAL DESCRIPTION SUMMARY: ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 06-OCT-2023: LEGAL CASE ¿ USA. PATIENT ID: (B)(6). IMPLANT DATE: (B)(6)2021, DR. (B)(6). EXPLANT DATE: (B)(6)2023, DR. (B)(6), OP REPORT ATTACHED. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY ATTACHED. ORIGINAL DESCRIPTION SUMMARY: LEGAL CASE: USA. PATIENT ID: (B)(6). 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) 2023, APPROXIMATELY 2 YEARS 2 MONTHS POST PRIMARY PROCEDURE. 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. EBI NOT FOUND.

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

  MAUDE report 21218333 ↗
• InjuryAug 21, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 33 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20012051 ↗
• InjuryFeb 2, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT UNDERWENT THEIR FIRST RIGHT KNEE REVISION ON (B)(6) 2021. THEY SUBSEQUENTLY UNDERWENT A SECOND RIGHT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 1 YEAR 7 MONTHS LATER. THE RE-REVISION SURGERY TOOK OVER FIVE HOURS AND REQUIRED PLACEMENT OF CONES AS WELL AS PLACEMENT OF A METAL WIRE IN THEIR FEMUR. 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: Discomfort; Failure of Implant; Muscle Weakness/Atrophy; Pain

  MAUDE report 18636813 ↗
• InjuryNov 21, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2017. APPROXIMATELY 5 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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 RIGHT TOTAL KNEE POLYETHYLENE DUE TO PREMATURE POLY WEAR AND POLY RECALL. FINDINGS: THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WAS FOUND TO BE WELL-FIXED FEMORAL, TIBIAL AND PATELLAR COMPONENTS WITH NO EVIDENCE OF SURROUNDING OSTEOLYSIS. THERE WAS A MILD AMOUNT OF POLYETHYLENE WEAR WITHIN THE TIBIAL POLYETHYLENE COMPONENT IN THE WEIGHTBEARING SURFACE WITH MILD PITTING. THERE WAS A MILD AMOUNT OF ENCAPSULATED POLYETHYLENE DEBRIS WITHIN THE SYNOVIUM AND A COMPLETE SYNOVECTOMY WAS PERFORMED. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY IN STABLE CONDITION.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 18183823 ↗
• InjurySep 21, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2021. APPROXIMATELY 2 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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. MASTER CASE NO. (B)(4). THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(4). 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 PA

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

  MAUDE report 17789857 ↗
• InjuryAug 15, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2017. APPROXIMATELY 5 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. 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 ON (B)(6) 2023. DIAGNOSIS: FAILED LEFT KNEE DUE TO PREMATURE POLY WEAR OF THE TIBIAL POLYETHYLENE AND LOOSE FEMORAL COMPONENT FINDINGS: THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WAS A MODERATE AMOUNT OF POLYETHYLENE WEAR, WHICH WAS VISIBLE WITH PITTING OF THE TIBIAL POLYETHYLENE. THERE WAS EVIDENCE OF ENCAPSULATED POLYETHYLENE DEBRIS WITH A THICKENED SYNOVIUM. A COMPLETE SYNOVECTOMY WAS PERFORMED. THERE WAS FOUND TO BE A LOOSE FEMORAL COMPONENT FROM THE CEMENT MANTLE. THERE WAS MILD OSTEOLYSIS OF THE FEMUR BEHIND THE CEMENT MANTLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 17550050 ↗
• InjuryJul 25, 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) 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 17393645 ↗
• InjuryJul 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2018. THEY UNDERWENT SUBSEQUENT LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 5 YEARS 3 MONTHS AFTER THEIR PRIMARY REPLACEMENT. ON (B)(6) 2023 OP REPORT POSTOPERATIVE DIAGNOSIS: LEFT TOTAL KNEE REVISION INSTABILITY OF LEFT KNEE. INTRAOPERATIVE FINDING INDICATED THAT THERE WAS SEVERE SYNOVITIS. THE POLYETHYLENE LINER APPEARED TO HAVE VERY MINIMAL WEAR, BUT THERE WAS MEDIAL LATERAL INSTABILITY THROUGHOUT THE RANGE OF MOTION. THERE WAS SEVERE WEAR OF THE PATELLAR COMPONENT. VERY MINIMAL OSTEOLYSIS WAS NOTED IN THE ANTERIOR FEMUR JUST PROXIMAL TO THE INTERCONDYLAR NOTCH. THE FEMORAL COMPONENT APPEARED TO BE WELL FIXED. PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY 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: Joint Laxity

  MAUDE report 17282835 ↗
• InjuryApr 27, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE RECALL, LINER WAS EXCHANGED. REASON FOR REVISION US UNKNOWN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING DUE TO HIPAA. N-RAYS ARE NOT AVAILABLE.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 16823558 ↗
• InjuryApr 14, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 AND THEN APPROXIMATELY LATER EXPERIENCED A REVISION SURGICAL PROCEDURE. IT IS STATED THAT THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT, AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN AND DISCOMFORT, SWELLING, STIFFNESS, GRINDING AND/OR POPPING OF THE KNEE, INABILITY TO BEAR WEIGHT, BUCKLING, GAIT IMPAIRMENT, AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 16744223 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM LEGAL THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A TOTAL LEFT KNEE REPLACEMENT AND WAS IMPLANTED WITH A TRULIANT DEVICE. THIS PATIENT HAS BILATERAL TKA. IN (B)(6) 2021, THE PATIENT WAS DESCENDING A SET OF STAIRS WHEN HER KNEES GAVE OUT. SHE FELL DOWN THE STAIRS AND FRACTURED HER RIGHT ANKLE. THIS INJURY RESULTED IN SIGNIFICANT PAIN AND REQUIRED EXTENSIVE REHABILITATION. SEVERAL MONTHS LATER, THE PATIENT SUFFERED ANOTHER FALL DUE TO WEAKNESS IN HER KNEES. THIS FALL RESULTED IN A LEFT FOOT FRACTURE. ON (B)(6) 2019, THE PATIENT REPORTED THAT THE PAIN, WEAKNESS, AND POPPING IN HER KNEES HAD BECOME INCREASINGLY WORSE OVER THE PAST YEAR. THE PATIENT¿S PHYSICIAN STATED THAT ¿A REVISION OF THE IMPLANT IS INDICATED TO RELIEVE THE PATIENT¿S PAIN¿. THE PATIENT AGREED TO UNDERGO A LEFT TOTAL KNEE REPLACEMENT REVISION SURGERY TO REMOVE THE TRULIANT DEVICE FROM HER LEFT KNEE, INFORMATION PROVIDED DOES NOT HAVE A DATE FOR THIS FUTURE SURGERY. 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 ADDITIONA

  Patient problems: Implant Pain

  MAUDE report 16626385 ↗
• InjuryMar 22, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED FROM LEGAL THAT ON (B)(6) 2019, THAT THE PATIENT UNDERWENT A TOTAL RIGHT KNEE REPLACEMENT AND WAS IMPLANTED WITH A TRULIANT DEVICE. IN (B)(6) 2021, THE PATIENT WAS DESCENDING A SET OF STAIRS WHEN HER KNEES GAVE OUT. SHE FELL DOWN THE STAIRS AND FRACTURED HER RIGHT ANKLE. THIS INJURY RESULTED IN SIGNIFICANT PAIN AND REQUIRED EXTENSIVE REHABILITATION. SEVERAL MONTHS LATER, THE PATIENT SUFFERED ANOTHER FALL DUE TO WEAKNESS IN HER KNEES. THIS FALL RESULTED IN A LEFT FOOT FRACTURE. ON (B)(6) 2023, THE PATIENT REPORTED THAT THE PAIN, WEAKNESS, AND POPPING IN HER KNEES HAD BECOME INCREASINGLY WORSE OVER THE PAST YEAR. THE PATIENT¿S PHYSICIAN STATED THAT ¿A REVISION OF THE IMPLANT IS INDICATED TO RELIEVE THE PATIENT¿S PAIN.¿ THE PATIENT UNDERWENT A RIGHT KNEE REPLACEMENT REVISION SURGERY ON (B)(6) 2023. FOLLOWING THE REVISION SURGERY, THE PATIENT WAS DIAGNOSED WITH ¿FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR SECONDARY TO A RECALLED POLYETHYLENE AND FEMORAL LOOSENING.¿ THE SURGEON NOTED ¿SOME SYNOVITIS WITH PARTICULATE DEBRIS CONSISTENT WITH POLYETHYLENE WEAR OR CEMENT DISEASE.¿ THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THER

  Patient problems: Implant Pain; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16590352 ↗
• InjuryFeb 15, 2023Naturally Worn; Patient Device Interaction Problem; Naturally Worn; Patient Device Interaction Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL RIGHT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2020 AND WAS IMPLANTED WITH A TRULIANT DEVICE, INCLUDING A TRULIANT POSTERIOR STABILIZED INSERT, SIZE 2.5, 9MM MADE OF POLYETHYLENE. PLAINTIFF UNDERWENT REVISION SURGERY OF HER RIGHT KNEE (B)(6) 2021, APPROXIMATELY 1 YEAR 9 MONTHS POST INITIAL PROCEDURE. UPON INFORMATION AND BELIEF, THE NEED FOR REVISION IN PLAINTIFF'S RIGHT KNEE WAS DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT. FOLLOWING THE REVISION SURGERY, PLAINTIFF CONTINUES TO BE LIMITED IN HER ACTIVITIES OF DAILY LIVING. DESPITE UNDERGOING REVISION SURGERY, PLAINTIFF EXPERIENCES DAILY PAIN AND DISCOMFORT IN HER RIGHT KNEE WHICH LIMITS HER ACTIVITIES OF DAILY LIVING AND IMPACTS HER QUALITY OF LIFE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Implant Pain

  MAUDE report 16378411 ↗
• MalfunctionNov 10, 2022Contamination; Contamination

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, ON THE BACK TABLE, A BLACK L SHAPE OBJECT WAS FOUND ON THE TRULIANT INSERT. THIS OBJECT WAS IN THE EVOH PACKAGE. THE SURGEONS WOULD LIKE TO KNOW WHERE THIS OBJECT CAME FROM. NO IMPACT TO A PATIENT SINCE THIS WAS FOUND BEFORE SURGERY. SURGICAL DELAY/PROLONGATION, LESS THAN 5 MINUTES. PCS WITH SAME SIZE INSERT WAS IMPLANTED. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15769699 ↗
• InjuryOct 18, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2020. THE PATIENT PRESENTED WITH DISCOMFORT, PAIN AND INSTABILITY ISSUES. THE PATIENT WAS REVISED ON (B)(6) 2020. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

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

  MAUDE report 15624016 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2021. THE PATIENT COMPLAINED OF PAIN AND HAD UNSATISFACTORY ISSUES WITH THE KNEE IMPLANTS. DUE TO THE RECALL, THE PATIENT WAS REVISED ON (B)(6) 2022. THE SURGEON USED COMPETITOR IMPLANTS FOR THE REVISION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 15588046 ↗