Optetrak Logic 02-012-44-5013Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10885862173737), received between Aug 12, 2020 and Dec 13, 2024 — classified as 20 injuries.

The most frequently reported specific device problem is “Naturally Worn” (14 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2024Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 03-OCT-2023. LEGAL CASE ¿ (B)(6). PATIENT ID: HECTOR RODRIGUEZ RK REV 1. RELATED (B)(4) RK REV 2. 8. PLAINTIFF WAS IMPLANTED WITH THE FOLLOWING EXACTECH DEVICE: OPTETRAK LOGIC 9. LEG IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: RIGHT. 10. DATE THE EXACTECH DEVICE WAS IMPLANTED: (B)(6) 2015 11. STATE IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: (B)(6). 12. DATE THE EXACTECH DEVICE WAS SURGICALLY REMOVED/REVISED: (B)(6) 2023. 13. PLAINTIFF HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS AS A RESULT OF THIS EXACTECH DEVICE: PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF¿S MOBILITY AND QUALITY OF LIFE AND NECESSITATED A REVISION SURGERY AND THE RESULTANT PAIN FOLLOWING SURGERY AND RECUPERATION/REHABILITATION PERIOD AND PHYSICAL THERAPY. PLAINTIFF¿S ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES HAS BEEN CONSEQUENTLY LIMITED. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. UNABLE TO LOCATE PATIENT IN EBI. NO SERIAL NUMBERS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL

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

  MAUDE report 20924836 ↗
• InjuryDec 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 76 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND PAIN. FOLLOWING INITIAL REVISION SURGERIES ON BOTH KNEES, THE PATIENT CONTINUED HAVING KNEE PAIN WHICH RESULTED IN NUMEROUS DOCTOR VISITS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 20835740 ↗
• InjuryNov 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE APPROXIMATELY 109 MONTH AFTER INITIAL IMPLANT DUE TO IMPLANT LOOSENING AND OSTEOLYSIS. LEFT KNEE ARTHROPLASTY FAILURE SECONDARY TO FEMORAL LOOSENING, FEMORAL AND TIBIAL OSTEOLYSIS, POLY INSERT HAD SIGNS OF DELAMINATION AND WEAR. PATIENT WAS EXPERIENCING SWELLING/EDEMA AND IMPLANT PAIN. 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; Implant Pain; Osteolysis; Swelling/ Edema

  MAUDE report 20784098 ↗
• InjuryJun 24, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE RIGHT KNEE, WITH NO REVISION SURGERY REPORTED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: INCREASING PAIN, SWELLING AND INSTABILITY IN HIS RIGHT KNEE. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 19601883 ↗
• InjuryApr 8, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, WITH NO REVISION SURGERY REPORTED. THERE IS NO DEVICE INFORMATION PROVIDED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19058230 ↗
• InjuryApr 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2019 APPROXIMATELY 2 YEARS AND 7 MONTHS AFTER INITIAL IMPLANT. THERE IS NO DEVICE INFORMATION PROVIDED. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19028504 ↗
• InjuryDec 7, 2023Mechanical Problem; Naturally Worn; Insufficient Device Problem Information; Mechanical Problem; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2017. APPROXIMATELY 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2017. 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, 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 18282283 ↗
• InjuryNov 6, 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. APPROXIMATELY 7 YEARS AND 7 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, 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: Failure of Implant; Insufficient Information; Osteolysis; Pain; Synovitis

  MAUDE report 18075124 ↗
• InjurySep 15, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, THEN APPROXIMATELY 6 YEARS, 4 MONTHS LATER, ON (B)(6) 2023 WAS SURGICALLY REVISED. REVISION OPERATIVE REPORT OF (B)(6) 2023 POST OPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE ARTHROPLASTY WITH LARGE OSTEOPHYTES OF THE PATELLA. MODERATE POLY WEAR OF THE POSTERIOR POLY OF THE POLY INSERT. SIGNIFICANT ARTHROFIBROSIS WITH MARKED ADHESIONS POSTERIORLY. REVISION TOTAL KNEE, EXTENSIVE SHARP DEBRIDEMENT, AND EXCISION OF MARKED SCAR TISSUE. PROCEDURE: SEVERE OSTEOPHYTES ON ALL 4 SIDES OF PATELLA ENCASED OVER THE PATELLA COMPONENT. PATELLA COMPONENT WAS REMOVED. POLY WAS REMOVED, THERE WAS MODERATE POSTERIOR WEAR BUT NO DEBONDING WAS NOTED. SURGEON STATES: ¿I BELIEVE MOST OF HIS PROBLEMS WERE RELATED TO HIS ARTHROFIBROSIS AND SCAR TISSUE.¿ THE PATIENT WAS AWAKENED, DRESSING APPLIED AND TAKEN TO RECOVERY ROOM PER ANESTHESIA. DISCHARGE SUMMARY- DIAGNOSIS: POLY WEAR OF RIGHT KNEE WITH RECALLED POLY. PROCEDURE: REVISION OF RIGHT KNEE POLY AND PATELLA. DISCHARGED HOME TO HAVE HOME PHYSICAL THERAPY AND HOME HEALTH. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE.

  Patient problems: Adhesion(s); Extraskeletal ossification; Failure of Implant; Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 17755598 ↗
• InjuryAug 10, 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 VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2015. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Arthritis; Insufficient Information; Pain

  MAUDE report 17500175 ↗
• InjuryJul 18, 2023Naturally Worn; Naturally Worn

  REVISION OPERATIVE REPORT- INSTABILITY OF PROSTHETIC KNEE ¿THERE WAS DELAMINATION OF THE POLYETHYLENE BUT NO EVIDENCE OF PROSTHESIS LOOSENING.¿ ¿THE PATELLA WAS ALSO NOT REMOVED BECAUSE IT [WAS] WELL FIXED WITH NO EVIDENCE OF POLYETHYLENE WEAR.¿ PER PATHOLOGY REPORT, ¿SCATTERED SMALL POLYETHYLENE PARTICLES AND SMALL METALLIC PARTICLES ARE PRESENT WITHIN THE HISTIOCYTIC INFILTRATE AND THE GIANT CELLS.¿ THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Deposits; Failure of Implant; Pain

  MAUDE report 17346693 ↗
• InjuryJun 29, 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) 2015. APPROXIMATELY 7 YEARS AND 2 MONTHS AFTER THE INITIAL SURGERY THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. 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; Insufficient Information; Osteolysis; Pain; Synovitis

  MAUDE report 17224368 ↗
• InjuryJun 22, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTS THAT A PATIENT WAS HAD AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2014 AND THEN APPROXIMATELY 8 YEARS, 8 MONTHS LATER EXPERIENCED A SURGICAL REVISION ON (B)(6) 2022. REVISION OPERATIVE REPORT OF (B)(6) 2022: FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO WEAR OF THE ARTICULAR BEARING SURFACE. PATIENT WAS REVISED TO A TRULIANT DEVICE. FINDINGS: 66 YO MALE PRESENTED AFTER HAVING THE RIGHT TOTAL KNEE IN 2016 WITH PAIN AND ACTIVITY DEPENDENT SWELLING OF THE RIGHT KNEE. HE HAD VERY LARGE SYNOVIAL EFFUSION WITH OBVIOUS SYNOVIAL EXPANSION ON PHYSICAL EXAM. X-RAY SHOWED A WELL-FIXED COMPONENT, BUT A LARGE SYNOVIAL FLUID ACCUMULATION. AT SURGERY, THEY FOUND CLEAR SYNOVIAL FLUID AND VERY, VERY SIGNIFICANT SYNOVIAL EXPANSION WITH A FOREIGN BODY TYPE REACTION APPEARANCE TO THE SYNOVIAL TISSUES. THE FEMORAL COMPONENT AND TIBIAL COMPONENTS WERE WELL FIXED. THE TIBIAL POLYETHYLENE INSERT SHOWED SIGNS OF SEVERE WEAR WITH GROSS PITTING AND ABRASIVE TYPE LOSS OF TISSUE AND SUBSTANCE FROM THE ARTICULAR SURFACE WITH SIGNIFICANT BACKSIDE WEAR AS WELL. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION; THERE WERE NO COMPLICATIONS. THERE IS NO OTHER PA

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

  MAUDE report 17182256 ↗
• InjuryApr 13, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE - (B)(6). (B)(4). RELATED CASE: (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT IS VERIFIED LEFT KNEE ON (B)(6) 2016 AND LEFT KNEE REVISION (B)(6) 2021, APPROXIMATELY 4 YEARS, 5 MONTHS AFTER INITIAL SURGERY. POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE REPLACEMENT SECONDARY TO INSTABILITY AND POLYETHYLENE WEAR. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE 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. SERIAL #: (B)(4), CATEGORY #: 02-012-44-5013 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM, SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K110547.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint Laxity; Joint effusion; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 16731641 ↗
• InjuryFeb 28, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A PATIENT, INITIAL RIGHT TKA, IMPLANTED WITH AN OPTETRAK POLYETHYLENE TIBIAL INSERT, ON (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 6 YEARS 8 MONTHS POST THE INITIAL PROCEDURE, DUE TO ¿OSTEOLYSIS¿ AND ¿SYNOVITIS SECONDARY TO POLYETHYLENE WEAR.¿ THE PLAINTIFF¿S REVISION SURGERY WAS DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE DEFECTIVE POLYETHYLENE INSERT COMPONENT WITHIN THE OPTETRAK DEVICE. AS A DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICES AS DESCRIBED HEREIN, PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES WHICH ALL REQUIRE ONGOING MEDICAL CARE. AS A FURTHER DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICES, PLAINTIFF HAS SUSTAINED AND WILL SUSTAIN FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE; REHABILITATION; HOME HEALTH CARE; LOSS OF EARNING CAPACITY; MENTAL AND EMOT

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 16456541 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO OTHER REASONS (FAILURE). INITIAL SURGERY DATE WAS (B)(6) 2012. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946556 ↗
• 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 LEFT 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 10946530 ↗
• InjuryNov 9, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2014, DUE TO RANGE OF MOTION/STIFFNESS. INITIAL SURGERY DATE WAS (B)(6) 2013. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10808454 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A (B)(6) Y/O, MALE PATIENT WITH A BMI OF 23.7, UNDERWENT IMPLANTATION OF A INSERT TIB 5 13MM KNEE POST STAB CNSTRN MOD NET CMPR MLD. ON (B)(6) 2019, APPROXIMATELY 4 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10574641 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A (B)(6) Y/O, MALE PATIENT WITH A BMI OF 44.2, UNDERWENT IMPLANTATION OF AN INSERT TIB 5 13MM KNEE POST STAB CNSTRN MOD NET CMPR MLD. ON (B)(6) 2018, APPROXIMATELY 8 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10398702 ↗