LPS 1987-13-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10603295078692), received between Aug 30, 2017 and Sep 30, 2026 — classified as 71 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50951663 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to fracture.DOI: Unknown,DOR: (b)(6) 2026,Affected side: Left Knee.

  Patient problems: Bone Fracture(s)

  MAUDE report 50544144 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY, SLEEVE, AND STEM AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION POST REVISION TKA. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED UTILIZING LPS COMPONENTS WITH HIGH DOSE ANTIBIOTICS AND RESORBABLE ANTIBIOTIC BEADS. SIGNIFICANT BONE LOSS WAS NOTED ON THE TIBIA AS THE INFECTION APPEARED TO HAVE BEEN PRESENT FOR SOME TIME BUT WAS UNTREATED UNTIL PATIENT SHOWED UP IN THE ER. NO DELAY OR PATIENT HARM WAS NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25503643 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS WITH DRAINING POST REVISION TKA THAT WAS TREATED WITH A STATIC SPACER FOR INFECTION. WHILE ASPIRATION PRIOR TO REIMPLANTATION WAS NEGATIVE FOR INFECTION, PATIENT NOW WAS POSITIVE FOR A FUNGAL INFECTION AND ALL COMPONENTS WERE REMOVED AN A NEW STATIC SPACER WAS PLACED IN CONJUNCTION WITH RESORBABLE ANTIBIOTIC BEADS LOADED WITH ANTIBIOTIC AND ANTIFUNGAL MEDICATION. NO DELAY NOR PATIENT HARM WAS NOTED. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24834914 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS WITH A RUPTURED EXTENSOR MECHANISM POST REVISION TKA. DUE TO SHORTENING OF THE SOFT TISSUES, THE SURGEON CHOSE TO REMOVE WELL FIXED, AND PREVIOUSLY WELL FUNCTIONING COMPONENTS, TO REDUCE TENSION ON THE RECONSTRUCTION OF PATIENT'S SOFT TISSUES. NO ALLEGATION WAS MADE AGAINST ANY LISTED COMPONENT. THIS IS A REPEAT RECONSTRUCTION THAT FAILED ON (B)(6) 2025 WHERE THE INSERT WAS EXCHANGED AT THAT TIME, BUT NO OTHER COMPONENTS WERE EXCHANGED. IT WAS THE SURGEON'S OPINION THAT SHORTENING THE FEMORAL CONSTRUCT GAVE THE PATIENT THE BEST OPPORTUNITY FOR A POSITIVE OUTCOME. NO DELAY NOR PATIENT HARM WAS NOTED. THE FEMORAL SLEEVE AND STEM WERE RETAINED FROM A TC3 REVISION. BASED UPON X-RAY, THE FEMORAL SLEEVE WAS A 31 OR 34MM AND THE STEM APPEARED TO BE 75 X 12MM. OUR RECORDS DO INDICATE THAT A 32MM SIGMA OVAL DOME PATELLA WAS PLACED ON THE ABOVE LISTED DATE, AND WAS STILL IN PLACE. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24334007 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND HAD A PARTIAL TEAR OF HIS PATELLAR TENDON POST REVISION TKA. ALL COMPONENTS WERE WELL FIXED AND WELL FUNCTIONING, SO NO CLAIM IS MADE AGAINST ANY COMPONENT. HOWEVER, DUE TO THE SHORT DURATION OF IMPLANTATION, THE FEMORAL SIDE COMPONENTS WERE REMOVED WHEN THE SURGEON ATTEMPTED TO SHORTEN THE CONSTRUCT. AS SUCH, THE FEMORAL SIDE COMPONENTS WERE PREPARED FOR AND NEW COMPONENTS WERE PLACED SHORTENING THE FEMORAL LENGTH TO PROTECT THE PATELLAR TENDON REPAIR. NO DELAY NOR PATIENT HARM OCCURRED. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 24132306 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS VERY SICK AND HAS FULL BODY INFECTION. PATIENT PRESENTED WITH BILATERAL KNEE AND SHOULDER INFECTIONS IN(B)(6) 2025 AND SURGEON WAS DOING EVERYTHING HE CAN TO CLEAR THE INFECTION. SURGEON ELECTED TO REMOVE DFR IMPLANT AND FUSE KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24051352 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANT STIFFNESS WITH ESSENTIALLY NO MOTION POST REVISION TKA FOR STIFFNESS. SURGEON IS NOT SURE WHY PATIENT IS SO STIFF AS NO INFECTION IS PRESENT BASED ON LABS AND FROZEN SECTION. ALL COMPONENTS WERE REMOVED. FEMORAL SLEEVE WAS NOT INGROWN ALMOST 5 MONTHS POST OP. THERE WAS NO RADIOGRAPHIC INDICATION THAT COMPONENT WOULD BE LOOSE. TIBIAL COMPONENTS WERE SUBSEQUENTLY REMOVED TO LOWER THE JOINT LINE AS THE PATELLA WAS IMPINGING THE INSERT AFTER REVISING THE FEMUR. THIS IS LIKELY A RESULT OF SHORTENING OF THE PATELLAR TENDON DUE TO LACK OF MOTION. TIBIAL SLEEVE WAS ONLY PARTIALLY INGROWN. NO DELAY NOR PATIENT HARM WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 23709414 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DRAINAGE SUGGESTING HE WAS STILL INFECTED. ALL WELL FIXED, WELL ALIGNED COMPONENTS WERE REMOVED. A THOROUGH DEBRIDEMENT WAS PERFORMED. BONE WAS THEN PREPARED FOR NEW IMPLANTS WHICH ARE PLACED WITH HIGH DOSE ANTIBIOTIC CEMENT ALONG WITH RESORBABLE BEADS THAT CONTAINED BOTH ANTIFUNGAL AND ANTIBIOTICS. NO DELAY WAS NOTED. PREVIOUS CEMENT WAS DEPUY 2 WITH GENT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 23099821 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ASPIRATED LAST WEEK AND IS NOW GROWING YEAST. ALL COMPONENTS WERE REMOVED IN A ONE STAGE REVISION AND NEW COMPONENTS WERE PLACED AFTER A THOROUGH I&D AND PLACEMENT OF RESORBABLE BEADS CONTAINING ANTIBIOTICS AND AN ANTIFUNGAL AGENT. ALL COMPONENTS WERE FUNCTIONING AS EXPECTED HOWEVER THE FEMORAL SLEEVE HAD FAILED TO INGROW, LIKELY DUE TO THE FUNGUS BEING PRESENT. TIBIAL COMPONENT AND CEMENTED STEM WERE PLACED ON THE ABOVE LISTED DATE. FEMORAL COMPONENTS AND INSERT HAD BEEN REVISED ON (B)(6) 2025 FOR CONTINUED INFECTION. A DER WAS FILED UNDER 1875689 PER OPTIMIZE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22748434 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUED TO DRAIN FROM KNEE WOUND. SURGEON ELECTED TO REMOVE KNEE PROSTHESIS AND FUSE THE KNEE. THIS COMPLAINT (B)(4) IS RELATED TO (B)(4). DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22329839 ↗
• 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 22214725 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO SHOW SIGNS OF INFECTION AND WAS BROUGHT TO THE OPERATING ROOM FOR BILATERAL KNEE REVISIONS. COMPONENTS WERE REMOVED AND THOROUGH I&DS WERE PERFORMED IN CONJUNCTION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS, AND PLACEMENT OF NEW COMPONENTS. PATIENT DID HAVE BILATERAL I&DS WITH POLY EXCHANGES ON (B)(6) 2025. AS SUCH, THE INSERTS LISTED ON THIS SUBMISSION WERE FROM THAT DATE. THE RIGHT KNEE SHOWED SIGNIFICANT HETEROTOPIC OSSIFICATION AROUND THE FEMORAL SLEEVE, SUGGESTING INFECTION ON XRAY, SO SURGEON TO CHOSE TO FASHION A STATIC SPACER UTILIZING LPS COMPONENTS TO TREAT THIS SIDE. THE LEFT SIDE APPEARED TO BE DOING BETTER, BUT SINCE HOSPITAL ADMISSION EARLIER THIS WEEK ALSO BEGIN TO SWELL. WHEN CHECKING FIXATION OF THE FEMORAL COMPONENT, THE FEMORAL SLEEVE WAS ABLE TO BE REMOVED WITHOUT SIGNS OF BONY INGROWTH. LACK OF INGROWTH APPROXIMATELY SEVEN (7) WEEKS POST IMPLANTATION SUGGESTS THIS TOO WAS INFECTED. TIBIAL COMPONENT AND STEM WERE LEFT IN PLACE ON THE LEFT SIDE SINCE IT WAS WELL FIXED. NO DELAY NOR PATIENT HARM WAS NOTED. WHILE RESULTS ARE NOT YET AVAILABLE, SURGEON DOES BELIEVE INFECTION WAS STILL PRESENT AT THE TIME OF THIS PROCEDURE

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 22160351 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE REVISION ON A DISTAL FEMUR DUE TO PATELLA INSTABILITY. PATELLA WAS NATURAL AND WAS NOT RESURFACED OR REVISED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22071133 ↗
• InjuryMay 2, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POOR PATELLAR TRACKING AND WAS SCHEDULED FOR SURGERY TO ADDRESS. AFTER EXPOSURE, SURGEON NOTED THE FEMORAL COMPONENT APPEARED TO BE INTERNALLY ROTATED. WHILE EXTRACTING THE FEMORAL COMPONENT HE NOTICED THAT THE FEMORAL SLEEVE ALSO MOVED INDICATING THAT IT HAD NOT YET INGROWN. THIS LED THE SURGEON TO BELIEVE THAT THE PATIENT COULD STILL BE INFECTED AS HE WAS TREATED AT THE PREVIOUS SURGERY WITH A ONE STAGE REVISION FOR INFECTION. FROZEN SECTION WAS SENT TO PATHOLOGY AND SHOWED 5 WHITE CELLS/ HIGH POWERED FIELD. THIS RESULT WAS MORE INDICATIVE OF A LOOSE COMPONENT THAN INFECTION BUT SURGEON FELT COMPELLED TO PROCEED AS IF INFECTED AND ALSO SENT CULTURES. FEMORAL COMPONENTS WERE REMOVED AND A THOROUGH DEBRIDEMENT AND IRRIGATION WAS PERFORMED. FEMUR WAS THEN PREPARED FOR NEW COMPONENTS AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY WAS ENCOUNTERED AND NO PATIENT HARM NOTED. PATELLAR TRACKING AND MOTION WERE FOUND TO BE IMPROVED WITH NEW COMPONENTS IN PLACE. THERE WAS LOOSENING REPORTED AT NON-CEMENTED INTERFACE AT FEMORAL SLEEVE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 21952674 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION OF A LEFT KNEE DISTAL FEMORAL REPLACEMENT. SURGEON REMOVED CERTAIN IMPLANTS AND PERFORMED I&D AND WASHOUT AND REPLACED IMPLANTS ALONG ANTIBIOTIC CEMENT. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21549783 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED ON A CALL LAST (B)(6) 2025, THE PATIENT HAD A ROD PLACED AND A REVISION OF THE KNEE WAS PERFORMED DUE TO LOWER FEMUR FRACTURE (SHATTERED) ON (B)(6) 2025. SINCE THAT TIME, THE PATIENT HAS HAD MULTIPLE "PARTIAL DISLOCATIONS" WHERE THE KNEE FEELS LIKE IT POPS OUT AND THEN HAS TO BE PUSHED BACK INTO PLACE. THE PATIENT HAS BEEN EXPERIENCING SEVERE PAIN DURING THOSE EPISODES.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21445218 ↗
• 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 20426549 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUES TO DRAIN POST REVISION TKA. SURGEON CHOSE TO REMOVE ALL MODULAR COMPONENTS AND PERFORM THOROUGH I&D. CULTURES WERE TAKEN TO RULE OUT INFECTION. TISSUES LOOKED SATISFACTORY AND LABS HAVE NORMALIZED. NO DELAY NOR PATIENT HARM OCCURRED. THERE IS NO ALLEGATION AGAINST COMPONENTS, SIMPLY EXCHANGED AS DRAINAGE THIS FAR POST REVISION COULD BE DUE TO A POTENTIAL INFECTION, ESPECIALLY WITH HER PREVIOUS HISTORY OF INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 20322405 ↗
• InjurySep 25, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SURGEON HAS HAD MULTIPLE FAIL TO INGROW WHEN UTILIZING FOR DISTAL FEMORAL REPLACEMENTS, SPECIFICALLY IN FEMALE PATIENTS SINCE TRANSITIONING FROM UNIVERSAL SLEEVES AND STEM FROM OUR PREVIOUS SYSTEM, TO ATTUNE STEMS AND FEMORAL SLEEVES. DUE TO REPEATED FAILURES, HE HAS TRANSITIONED BACK TO THE PREVIOUS VERSION FOR THIS TYPE OF PROCEDURE. HE USED THE PREVIOUS VERSION FOR MULTIPLE YEARS IN HIGH VOLUME WITH RARE FAILURES. DOI: UNKNOWN DOR: UNKNOWN AFFECTED SIDE : LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20301860 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUED TO DRAIN AND WAS TAKEN BACK TO THE OPERATING ROOM TO INVESTIGATE THE CAUSE. FROZEN SECTIONS WERE NEGATIVE HOWEVER THERE WAS OOZING STILL NOTED IN THE TISSUES AND THESE WERE ADDRESSED OPERATIVELY. THERE WAS NO ALLEGATION AGAINST ANY COMPONENT AS THE KNEE WAS FUNCTIONING PROPERLY, HOWEVER DUE TO THE EXTENDED DRAINAGE THE SURGEON CHOSE TO EXCHANGE MODULAR COMPONENTS. NO DELAY WAS EXPERIENCED OR PATIENT HARM OCCURRED. DOI: ON (B)(6) 2024. DOE: ON (B)(6) 2024.

  Patient problems: Fluid Discharge

  MAUDE report 20015166 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RUPTURED HER PATELLAR TENDON. THE SURGEON FELT HE NEEDED TO SHORTEN THE WELL FIXED AND WELL FUNCTIONING FEMORAL CONSTRUCT IN OR TO REPAIR THE TENDON AND APPROPRIATELY ALIGN THE PATELLA WITH THE FEMORAL COMPONENT. THERE WERE NO ALLEGATIONS TOWARDS ANY DEPUY PRODUCTS. FEMORAL COMPONENTS WERE REMOVED UNEVENTFULLY AND NEW COMPONENTS WERE PLACED WITHOUT DELAY NOR PATIENT HARM. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19917749 ↗
• InjuryMay 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO.

  Patient problems: Joint Dislocation; Joint Laxity; Physical Asymmetry

  MAUDE report 19286583 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DISLOCATED AGAIN FROM A COMPETITIVE CONSTRAINED LINER. SURGEON CHOOSE TO REMOVE THE COMPETITIVE CUP AND PLACE A DEPUY CUP AND CONSTRAINED LINER. UNFORTUNATELY, AFTER BEING REPEATED FAILURES WITH THE COMPETITIVE LINER THE SURGEON HAD STRONG SUSPICION OF INFECTION DUE TO ELEVATED LABS AND CHOSE TO CHANGE ALL MODULAR COMPONENTS AND PLACE RESORBABLE ANTIBIOTIC BEADS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19191573 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A FALLL AND RUPTURED THE PATELLAR TENDON. TO APPROPRIATELY REPAIR, SURGEON CHOSE TO SHORTEN THE FEMORAL CONSTRUCT BUT TO DO SO HAD TO REMOVE WELL FIXED COMPONENTS. STEM AND SLEEVE HAD BEEN PLACED ON (B)(6) 2023 AS PART OF A SPACER AND WAS RETAINED WHEN CONVERTED TO A DISTAL FEMUR ON THE DATE LISTED ON THE FORM. NO DELAY WAS EXPERIENCED AND NO HARM OCCURRED. DOI:(B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 19153166 ↗