Optetrak Logic 02-012-44-4015Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10885862173669), received between Aug 12, 2020 and Jan 8, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Naturally Worn” (13 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-0021-2022 · 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.

• InjuryJan 8, 2026Unstable; Naturally Worn

  REPORT 2 OF 2 FOR THIS EVENT: IT WAS REPORTED A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, FIVE (5) YEARS, SIX (6) MONTHS LATER, THE PATIENT EXPERIENCED LEFT KNEE INSTABILITY AND SIGNIFICANT PAIN. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING AND PROSTHESIS WEAR. IT WAS REPORTED THAT INTRAOPERATIVELY THE SURGEON OBSERVED SIGNIFICANT LOOSENING OF THE FEMORAL COMPONENT, SUBSIDENCE, POLYETHYLENE COMPONENT WEAR, SYNOVITIS, AND OSTEOLYSIS. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 24009355 ↗
• InjuryJan 23, 2025Naturally Worn; Naturally Worn

  LEGAL CASE-USA: PATIENT ID: (B)(6) RK REV. ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 13-DEC-2023: REVISION OPERATIVE REPORT OF (B)(6) 2023 - POSTOPERATIVE DIAGNOSIS- FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC FEMORAL LOOSENING, OSTEOLYSIS; MORBID OBESITY BMI 41. PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. MARKED SYNOVITIS. EVIDENCE OF POLYETHYLENE WEAR ON THE UNDERSURFACE OF THE PATELLA. NO GROSS EVIDENCE OF POLYETHYLENE WEAR OF THE ACTUAL INSERT. STERILE DRESSINGS WERE APPLIED, AND THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM. THERE IS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. THERE ARE NO X-RAYS OR IMAGES PROVIDED. DEVICES WERE NOT RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. UNABLE TO LOCATE EBI. REVISION PRODUCT: DEPUY ATTUNE KNEE SYSTEM COMPONENTS; STRYKER SIMPLEX BONE CEMENT. ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 27-OCT-2023: THIS MORNING, I TALKED TO (B)(6) ABOUT (B)(6)'S CLAIM. BELOW IS A SUMMARY OF THAT CALL: (B)(6) UNDERWENT KNEE REPLACEMENT FOR BOTH KNEE IN APPROXIMATELY (B)(6) 2013: HE REVISED HIS RIGHT KNEE ON (B)(6) 2023 RIGHT KNEE. (B)(6) CLAIMS HIS RECOVERY PERIOD WAS TOUGH AND HE WAS IN SEVERE PAIN BEFORE THE

  Patient problems: Osteolysis; Pain; Synovitis

  MAUDE report 21217243 ↗
• InjuryJan 7, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 64 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, INSTABILITY AND PAINFUL LEFT KNEE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED LEFT TOTAL KNEE ARTHROPLASTY LOOSENING. INTRAOPERATIVELY THE SURGEON OBSERVED THE PATELLA BUTTON AND POLYETHYLENE INSERT WELL FIXED. THE FEMORAL COMPONENT WAS NOTED AS WELL FIXED AND REMAINED ATTACHED TO THE FEMUR, ALTHOUGH DEBONDED FROM THE CEMENT. OSTEOLYSIS WAS OBSERVED AROUND THE FEMORAL COMPONENT. IT WAS NOTED THE TIBIAL COMPONENT WAS SIGNIFICANTLY LOOSE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Joint Laxity; Osteolysis; Pain

  MAUDE report 21092648 ↗
• InjuryOct 2, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA LETTER OF PRESERVATION. (B)(4) LK IS ASSOCIATED WITH THIS CASE. NOTICE OF PRESERVE PATHOLOGY AND EXPLANT MATERIALS. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 65 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. 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-0021-2022.

  Patient problems: Insufficient Information

  MAUDE report 20354659 ↗
• InjuryJul 18, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 130 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19778677 ↗
• InjuryMay 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 107 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SWELLING, DELAMINATION, CYST. 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: Cyst(s); Failure of Implant; Swelling/ Edema

  MAUDE report 19310905 ↗
• InjuryMay 9, 2024Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 95 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, FEMORAL DEBONDING, OSTEOLYSIS, AND INSTABILITY. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Loss of Range of Motion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 19278046 ↗
• InjuryMar 4, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2020 APPROXIMATELY 4 MONTHS AFTER SECOND REVISION. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Medical device site infection

  MAUDE report 18824626 ↗
• InjurySep 26, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2016. DEVICE HAS NOT BEEN EXPLANTED. ON (B)(6) 2022, THE PATIENT CONTACTED THE PHYSICIAN AND REPORTED SWELLING AND PAIN ON THE LATERAL ASPECT OF HIS RIGHT KNEE. HE REQUESTED A DIAGNOSTIC WORK-UP OF HIS RIGHT KNEE. THE DOCTOR'S OFFICE RECOMMENDED THAT THE PATIENT CONTINUE WITH THE PLAN TO SURGICALLY REVISE HIS LEFT KNEE BEFORE BEGINNING WORK UP ON THE RIGHT KNEE. SPECIFICALLY, HE WAS INFORMED THAT HE SHOULD WAIT TO PERFORM A WORK UP OF HIS RIGHT KNEE UNTIL AFTER HIS LEFT KNEE SURGERY TO ENSURE UP TO DATE IMAGING AND TESTING IS OBTAINED AND TO ENSURE THAT HIS LEFT KNEE HEALED ENOUGH TO PURSUE REVISION RIGHT KNEE SURGERY IF NECESSARY. THE PATIENT WAS ORDERED TO TAKE ANTI-INFLAMMATORIES TO HELP MANAGE THE PAIN. AS TO HIS RIGHT KNEE, THE PATIENT HAS EXPERIENCED PAIN AND DISCOMFORT FROM OVER-USE/OVER-COMPENSATING. 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. MDL NO. (B)(4). THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC P

  Patient problems: Discomfort; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 17816844 ↗
• InjurySep 15, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017 THEN APPROXIMATELY 5 YEARS LATER, ON (B)(6) 2022 UNDERWENT A REVISION SURGICAL PROCEDURE. THE PATIENT COMPLAINS OF: PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH NEGATIVELY AFFECTED MOBILITY AND QUALITY OF LIFE AND NECESSITATED A REVISION 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 ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 17754964 ↗
• InjuryJun 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A 66 YEAR OLD MALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 9 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022 DUE TO SWELLING AND PAIN. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: FAILED LEFT KNEE SECONDARY TO WEAR OF THE BEARING SURFACE FINDINGS: DURING THE SURGERY THE PATIENT WAS FOUND TO HAVE A LARGE SYNOVIAL EFFUSION, SYNOVIAL EXPANSION, SYNOVIAL FLUID CONSISTENT WITH POLYETHYLENE WEAR. THE FEMORAL, TIBIAL AND PATELLAR COMPONENTS ALL WERE WELL FIXED. THE PATIENT HAD EXUBERANT SYNOVITIS UPON ENTERING THE JOINT TYPICAL OF THE FOREIGN BODY TYPE REACTION SYNOVIUM. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THE PATIENT WAS AWAKENED, TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint effusion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17071663 ↗
• InjuryApr 27, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PER A REPORT FROM THE LEGAL DEPARTMENT THE MALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023 DUE TO PAIN. REVISION OP REPORT - (B)(6) 2023 PATIENT HAD SEVERE PAIN DUE TO FAILED ASEPTIC LOOSENING OF LEFT TOTAL KNEE REPLACEMENT. LOOSE FEMORAL AND TIBIAL IMPLANTS - REMOVED EASILY WITH MODERATE BONE LOSS. THERE WAS EXTENSIVE SOFT TISSUE DEBRIS THROUGHOUT THE KNEE JOINT CONSISTENT WITH A SYNOVITIS FROM A POLYETHYLENE REACTION TO THE TISSUES. THIS WAS TINY, SMALL BALLS OF LIGHT BROWN SYNOVIUM ALONG WITH A "PSEUDO-CAPSULE" OF DENSE SOFT TISSUE RIND. THE SURGEON RESECTED AS MUCH OF THIS AS SAFELY POSSIBLE. THE TOTAL AMOUNT OF SOFT TISSUE DAMAGE THAT REQUIRED RESECTION WAS ~ 6 OZ. THE SURGEON EXAMINED THE POLYETHYLENE - EXCESSIVE WEAR WAS PRESENT WITH SIGNS OF OXIDATION / YELLOW DISCOLORATION, PITTING, CRACKING, AND DELAMINATION OF THE POLY. DISTAL FEMORAL BONE LOSS WAS MODERATE. THIS DID NOT REQUIRE A FEMORAL CONE. LARGE MEDIUM GRAPE SIZE BONE DEFECT (UNCONTAINED) ALONG THE MEDIAL POSTERIOR TIBIA AS A RESULT OF OSTEOLYSIS. THE TIBIAL BONE LOSS WAS EXTENSIVE AND REQUIRE

  Patient problems: Synovitis

  MAUDE report 16824050 ↗
• InjuryMar 23, 2023Appropriate Device Problem Term/Code Not Available; Noise, Audible; Lack of Effect; Appropriate Device Problem Term/Code Not Available; Noise, Audible; Lack of Effect

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 62 YO MALE PATIENT EXPERIENCED ARTHROFIBROSIS AND PATELLAR CLUNK RESULTING IN PAINFUL CATCHING AND CLICKING IN THE L KNEE. THE DATE OF ADVERSE EVENT ONSET IS (B)(6) 2017. THE PATIENT WAS TREATED WITH PHYSICAL THERAPY AND BRACING. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2018.

  Patient problems: Arthrofibrosis; Pain

  MAUDE report 16599755 ↗
• InjuryNov 10, 2022Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2017, WAS REVISED ON (B)(6) 2022, APPROXIMATELY 4 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE REPORTED INFORMATION INDICATED THAT IN THE MIDDLE OF 2020, THE PATIENT BEGAN EXPERIENCING SEVERE PAIN, SWELLING, AND INSTABILITY IN HIS RIGHT KNEE. AN MRI PERFORMED ON (B)(6) 2021, ON THE PATIENT¿S RIGHT KNEE DEMONSTRATED A ¿POLYMERIC-INDUCED SYNOVITIS¿, ¿FOCAL FEMORAL OSTEOLYSIS, AND PROMINENT FIBROUS INTERFACE OVER THE PATELLA COMPONENTS¿, ¿DEFICIENCY OF THE FIBULAR COLLATERAL LIGAMENT AND DEGENERATION OF THE POPLITEUS TENDON.¿ THE PATIENT'S CLINICAL, LABORATORY, AND RADIOLOGICAL WORKUP ON HIS RIGHT KNEE WAS NEGATIVE FOR INFECTION, BUT POSITIVE FOR LOOSENING SECONDARY TO OSTEOLYSIS SECONDARY TO POLYETHYLENE WEAR. NO DEVICE RETURNING DUE TO THIS BEING A LEGAL CASE.

  Patient problems: Implant Pain; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15777282 ↗
• InjurySep 29, 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 VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2013, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020, APPROXIMATELY 6 YEARS 11 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR REASONS UNKNOWN. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Joint Laxity; No Clinical Signs, Symptoms or Conditions; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15503860 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT RECEIVED A RIGHT KNEE TRULIANT IMPLANT DATE: (B)(6) 2018, REVISION DATE: (B)(6) 2021. NO OTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15334932 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL TEAM, APPROXIMATELY THREE YEARS POST INITIAL LEFT TKA, THIS MALE PATIENT HAD A REVISION FOR AN UNKNOWN REASON. NO OTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 14074588 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, PATIENT PRESENTED WITH INSTABILITY AND A POLY EXCHANGE WAS PERFORMED WHERE THE SURGEON WENT TO A THICKER INSERT. THE TIBIA AND FEMUR WERE WELL FIXED. IMAGES WERE RECEIVED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 13426044 ↗
• InjuryFeb 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 11 YEARS AND 4 MONTHS POST LEFT SIDE TKA, THIS MALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13417144 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2015, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2015. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10946513 ↗
• InjuryDec 4, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2014. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946502 ↗
• InjuryNov 2, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2013, DUE TO RANGE OF MOTION/STIFFNESS. INITIAL SURGERY DATE WAS (B)(6) 2011. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10775678 ↗
• InjuryAug 12, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2019, A (B)(6) Y/O, MALE PATIENT WITH A BMI OF 27.5, UNDERWENT IMPLANTATION OF A INSERT TIB 4 15MM KNEE POST STAB CNSTRN MOD NET CMPR MLD. ON (B)(6) 2019, APPROXIMATELY 10 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING.

  Patient problems: Failure of Implant

  MAUDE report 10399791 ↗