NA 1294-53-216Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10603295026273), received between Sep 8, 2017 and Feb 27, 2026 — classified as 79 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (19 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED A FALL POST TOTAL KNEE ARTHROPLASTY (TKA), RESULTING IN A TORN SURGICAL REPAIR AND DAMAGE TO THE QUADRICEPS MECHANISM. THE SURGEON DETERMINED THAT SHORTENING THE FEMORAL CONSTRUCT WOULD REDUCE TENSION ON THE REPAIR, LEADING TO REMOVAL OF THE FEMORAL COMPONENTS AND EXCHANGE OF THE PATELLAR COMPONENT TO A CEMENTED VERSION. ALL COMPONENTS WERE FUNCTIONING WELL PRIOR TO THE FALL, AND THERE WAS NO DELAY OR ADDITIONAL PATIENT HARM NOTED. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 24474482 ↗
• InjuryJan 13, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE SLEEVE FAILED TO INGROW AND STEM BOLT BROKE. SURGEON ELECTED TO CHANGE TO AN ATTUNE SLEEVE AND LONGER STEM. IT WAS STATED THAT THE SLEEVE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. ALL THE PIECES WERE RETRIEVED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24050749 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMUR AT CEMENT TO IMPLANT INTERFACE AND STABILITY. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A PREVIOUS TRAUMATIC INJURY. THE PREVIOUS IMPLANTS WERE UPSIZED BECAUSE OF LOOSENING IN THE TIBIA AND FEMUR AND THE ACTUAL POLYETHYLENE WAS NOT WORN OUT. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23992701 ↗
• InjuryDec 16, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO FEMORAL SLEEVE AND STEM APPEAR LOOSE ON XRAY. FEMORAL SIDE COMPONENTS ARE REMOVED AND NEW COMPONENTS ARE PLACED WITHOUT DELAY OR HARM. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23818544 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY OPERATED ON FOR AN INFECTED NON-UNION OF FUSION. SINCE CULTURES WERE NEGATIVE, SURGEON CHOSE TO REIMPLANT THE PATIENT. CONTINUED DRAINAGE SUGGESTS INFECTION. SINCE THE PATIENT CONTINUES TO DRAIN DESPITE NEGATIVE CULTURES, THE SURGEON CHOSE TO REMOVE ALL COMPONENTS AND CONVERT TO A STATIC SPACER UTILIZING LPS COMPONENTS, PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND HIGH DOSE ANTIBIOTIC CEMENT TO COAT THE COMPONENTS. ALL COMPONENTS WERE WELL FIXED BUT LACK OF BONY INGROWTH ALSO SUGGESTS PERSISTENT INFECTION. AN I&D WAS PERFORMED ON (B)(6) 2025, WHERE THE POLY AND PIN WERE REPLACED. DEPUY 2 WITH GENTAMICIN WAS LIKELY UTILIZED, AS THAT IS THE SURGEON'S NORM. NO DELAY OCCURRED AND NO PATIENT HARM WAS NOTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22214713 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL RIGHT KNEE. SURGEON CONVERTED FROM A TC3 TO DISTAL FEMORAL REPLACEMENT. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21596897 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTS WERE REMOVED DUE TO INFECTION. A SPACER WAS PLACED UTILIZING LPS COMPONENTS IN A DUAL SET UP FASHION IN CONJUNCTION WITH A THOROUGH I&D WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY NOR PATIENT HARM TOOK PLACE. NO ALLEGATION WAS MADE AGAINST ANY COMPONENTS AT THIS TIME, AS ALL WERE WELL FIXED AND WELL FUNCTIONING. FEMORAL SIDE HAD BEEN REVISED ON (B)(6) 2023 AND AGAIN ON (B)(6) 2024. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20426482 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN TO DRAIN AGAIN POST ANTIBIOTIC SPACER FASHIONED WITH LPS COMPONENTS. ALL COMPONENTS WERE REMOVED. DURING DISSECTION AND REMOVAL, A VASCULAR INJURY OCCURRED. THE VASCULAR TEAM CAME IN TO REPAIR THE VESSELS. A NEW SPACER UTILIZING LPS COMPONENTS WAS PLACED AFTER A THOROUGH DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS A DELAY IN THE PROCEDURE AND HARM DID OCCUR BUT THERE WAS NO MENTION OF ALLEGATION AGAINST ANY DEPUY COMPONENTS CAUSING SAID INJURY. DOI: (B)(6) 2024 DOR: (B)(6), 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Perforation of Vessels

  MAUDE report 20239517 ↗
• InjurySep 12, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PATIENT RECEIVED A REVISION IN 2016. PATIENT BOOKED FOR A RE-REVISION (B)(6) 2024. WHEN PATIENT OPENED, IT WAS NOTED BY SURGEON THAT THE TC3 APPEARED LOOSE AND TO ROTATE IN THE INSERTED FEMORAL SLEEVE.

  Patient problems: Insufficient Information

  MAUDE report 20199056 ↗
• InjuryApr 24, 2024Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED. NO SURGICAL DELAY IN EITHER CASE (THE FIRST LPS DFR, NOR THE REVISION LPS DFR). THE FAILURE OCCURRED, AT THE SLEEVE/STEM CONNECTION. THE THREADS OF THE STEM BROKE OFF INSIDE THE SLEEVE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19172554 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE : UNKNOWN

  Patient problems: Pain

  MAUDE report 18856580 ↗
• InjuryFeb 13, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSE FEMORAL COMPONENTS. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18695179 ↗
• InjurySep 26, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT AT UNKNOWN INTERFACE. SURGEON REMOVED IT AND REPLACED WITH A TC3 FEMUR/ SLEEVE/STEM/ AUGMENTS. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17816188 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON CONVERTED A PROXIMAL FEMUR TO LPS TOTAL FEMUR FOR STABILITY REASONS. THERE WAS NO SURGICAL DELAY AND NO CEMENT INFORMATION AVAILABLE FOR PRIMARY OR CURRENT SURGERY. DOI: (B)(6) 2022. DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16910137 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND STERLING AND WAS TESTED FOR NICKEL ALLERGY. THE TEST CAME BACK POSITIVE SO THE SURGEON TOOK IT ALL OUT AND PUT IN AN AESCULAP REVISION CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16584666 ↗
• InjuryMar 13, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT (NON CEMENTED). DISTAL FEMORAL REPLACEMENT DONE. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16529041 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL RIGHT KNEE. DOI: (B)(6) 2016, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15586751 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE INSERTED ON 2 DIFFERENT DATES AS A PARTIAL REVISION WAS PERFORMED ON THE SECOND DATE, 5-57-21. A DER WAS SUBMITTED AT THAT TIME. FIRST 3 ITEMS LISTED WERE LEFT FROM 1-29-20 PROCEDURE, THE REST WERE PLACED IN MAY 21. PATIENT COMPLAINED OF TIBIAL PAIN. XRAYS APPEARED TO HAVE LUCENCIES ON THE TIBIAL SIDE SO A TIBIAL SIDE REVISION WAS PLANNED. INSERT AND FEMORAL COMPONENT WERE REMOVED FOR EXPOSURE, THEN TIBIAL TRAY AND STEM WERE REMOVED, BUT THE TIBIAL SLEEVE WAS FOUND TO BE WELL FIXED. THE SURGEON WANTED TO SHORTEN THE ADAPTER ON THE FEMORAL SLEEVE AND WHEN TRYING TO REMOVE THE ADAPTER THE FEMORAL SLEEVE AND STEM WERE EXTRACTED. AT THIS POINT, A TIBIAL AND FEMORAL REVISION WERE PERFUMED UNEVENTFULLY. THERE WAS NO PATIENT HARM. DOI: (B)(6) 2020 DOR: (B)(6) 2022 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15526005 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT RESECTION WAS PERFORMED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14142295 ↗
• InjuryMar 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTED LEFT KNEE. EXTRACTION OF COMPONENTS AND INSERTION OF ANTIBIOTIC SPACER WERE DONE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE AFFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 13925415 ↗
• InjuryFeb 17, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  AMPUTATION: THE PATIENT RECEIVED AN ABOVE THE KNEE AMPUTATION DUE TO SIGNIFICANT PAIN, INFECTION, SWELLING, DRAINING, LYMPHEDEMA AND INABILITY TO AMBULATE. UPON ENTERING THE JOINT, THE CONSTRUCT WAS NOTED TO BE GROSSLY LOOSE AND INFECTED. THE AMPUTATION WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2017, DOR: (B)(6) 2021, UNKNOWN KNEE. THIS COMPLAINT IS ALSO LINKED TO (B)(4) WHERE THE TIBIAL TRIAL WAS REPORTED. ANOTHER PC IS LINKED TO THIS COMPLAINT UNDER (B)(4) WHERE THE EVENT HAPPENED IN BETWEEN APR 2017 - MAR 2019.

  Patient problems: Ambulation or Postural Difficulties; Fluid Discharge; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13549612 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS 2 STAGE INFECTION WAS REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Fluid Discharge; Loss of Range of Motion; Necrosis; Pain; Unspecified Infection

  MAUDE report 13533850 ↗
• InjuryNov 9, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH PAIN IN FEMUR AND X-RAYS SHOW WHAT APPEARS TO BE A LOOSE FEMORAL SLEEVE. PATIENT IS TAKEN TO OR TO REVISE FEMORAL IMPLANT WITH SUSPICION OF INFECTION DUE TO HIS REPEATED INFECTION HISTORY. FROZEN SECTION SHOWED 7 WHITE CELLS PER HPF. SURGEON CHOSE TO REMOVE ALL COMPONENTS AND REPLACE THE KNEE IN A ONE STAGE REVISION UTILIZING A DUAL STAGE SET UP. ANTIBIOTIC BEADS WERE PLACED IN ADDITION TO COATING THE NON ARTICULATING PORTION OF THE COMPONENT WITH HIGH DOES ANTIBIOTIC CEMENT. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 12779142 ↗
• InjuryNov 7, 2021Osseointegration Problem; Osseointegration Problem

  TODAY A FULL NOILES CONSTRUCT WAS REVISED. THE REASON FOR THE REVISION WAS FOR ASEPTIC LOOSENING OF THE EXISTING IMPLANTS. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12758654 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO LOOSENING REPORTED. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12719429 ↗