LPS 1987-27-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295079330), received between Oct 13, 2017 and Apr 24, 2026 — classified as 46 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Naturally Worn

  IT WAS REPORTED THAT PATIENT HAS NOT HAD A QUADRICEPS MECHANISM POST REVISION TKA ON THE ABOVE LISTED DATE. SURGEON PLACED AN ALLOGRAFT PATELLAR TENDON AND CHOSE TO EXCHANGE COMPONENTS DUE TO DURATION IN VIVO. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT HOWEVER WEAR WAS NOTED ON THE INSERT THAT WAS BELIEVED TO BE ASSOCIATED WITH LACK OF A QUADRICEPS MECHANISM. NO DELAY NOR PATIENT HARM WAS NOTED. SURGEON DID NOT EXCHANGE THE DISTAL FEMORAL COMPONENT DUE TO LACK OF AVAILABILITY. THIS IS NOT CONSISTENT WITH NORMAL REVISION PROTOCOL. DOI: ON (B)(6) 2018, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24979687 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED HEMATOMAS POSTOPERATIVELY. PATIENT WAS BROUGHT TO OR FOR BILATERAL I&DS WITH POLY EXCHANGES. THERE ARE NO ALLEGATIONS AGAINST ANY COMPONENTS. THERE WAS NO DELAY OR PATIENT HARM. SURGEON FELT LIKE EARLY INTERVENTION WOULD LESSEN THE LIKELIHOOD OF INFECTION. AFFECTED SIDE: RIGHT.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 21676039 ↗
• 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 21549791 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED DISTAL FEMUR REPLACEMENT-POLY, BUMPER, AND PIN SWAP. DISTAL FEMUR IMPLANT STAYED, NEW PIN, BUMPER, AND POLY. NO IMPLANT FAILURE. ALL PIECES RETRIEVED. NO DELAY. SAME SIZES BACK IN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21136965 ↗
• 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 19191454 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE PATIENT RUPTURED HER PATELLAR TENDON. THE FEMORAL CONSTRUCT WAS SHORTENED TO ENABLE REPAIR. DO DELAY WAS EXPERIENCED AND NO PATIENT HARM WAS NOTED. DOI: (B)(6) 2018. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19020319 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED THROUGH THE EMERGENCY ROOM WITH SUSPECTED INFECTION. ASPIRATION CONFIRMED THE INFECTION. ALL COMPONENTS WERE REMOVED, A THOROUGH DEBRIDEMENT WAS PERFORMED, AND A SPACER AND RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN A DUAL SET UP FASHION. TIBIAL COMPONENTS WERE PLACED SOMEWHERE ELSE AT AN UNKNOWN TIME AND LOCATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17119040 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? --> NO. B. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? --> NO. C. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? --> NO D. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? --> JOINT LINE WAS SET BY PREVIOUS SURGERY. E. PLEASE CLARIFY IF THE PATIENT'S PATELLA HAD ALREADY RESURFACED PRIOR TO THIS REVISION, AND IF SO, WAS THE PATELLA PRODUCT A DEPUY PATELLA IMPLANT? IF IT IS, IT WILL NEED TO BE ADDRESSED FOR JOINT INSTABILITY FOR THE PATELLA TRACKING ISSUES. --> IT HAD AN UNIDENTIFIABLE IMPLANT IN PLACE AND REMAINED.

  Patient problems: Joint Laxity; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 17038471 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEVERE RHEUMATOID ARTHRITIS AND DEVELOPED A SIGNIFICANT FLEXION CONTRACTURE. THE SURGEON'S BELIEF WAS THE EASIEST WAY TO ADDRESS WAS TO SHORTEN THE FEMORAL SIDE. THE FEMORAL COMPONENT WAS REMOVED, THE FEMUR RESECTED UNTIL THE KNEE WOULD STRAIGHTEN AND NEW COMPONENTS WERE PLACED WITH NO COMPLICATIONS OR HARM. NO SURGICAL DELAY. DOI: (B)(6) 2014. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 14955936 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO OPEN INFECTED WOUND OF A RIGHT DISTAL FEMORAL REPLACEMENT. PATIENT FELL ON RIGHT KNEE AND FRACTURED PATELLA. THERE IS NO REPORTED LOOSENING. NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 14490218 ↗
• InjuryMay 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD FEMORAL REVISION ON (B)(6) 2022 FOR A DISLOCATED POLY ALSO. FEMORAL SIDE IMPLANTS WERE PLACED AT THAT TIME TO INCLUDE THE INSERT. TIBIAL COMPONENTS WERE PLACED AT THE ABOVE LISTED DATE. PATIENT PRESENTS WITH A DISLOCATED POLY AGAIN. TIBIAL SIDE REVISION WAS PERFORMED AS SURGEON BELIEVES HIS PATELLA TENDON HAS NOW SHORTENED TO THE POINT THAT THE JOINT LINE IS NOW INCORRECT LEADING TO THE RECURRENT DISLOCATIONS. CEMENT WAS LIKELY A DEPUY PRODUCT BUT WOULD HAVE BEEN HOSPITAL INVENTORY SO NO LOT OR QUANTITY INFORMATION IS AVAILABLE. THE PIN WAS CHANGED TO THE ONE THAT CAME WITH THE NEW DISTAL FEMORAL COMPONENT. DOI- (B)(6), 2022. DOR- (B)(6), 2022. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Dislocation; Joint Laxity; Muscle/Tendon Damage

  MAUDE report 14287113 ↗
• InjuryApr 13, 2022Fracture; Fracture

  DISLOCATION OF LPS UNIVERSAL KNEE BEARING. BEARING (INSERT / ARTICULATING SURFACE) BREAKAGE AND DISLOCATION. THE BEARING BREAKAGE DISLODGED THE METAL REINFORCEMENT POST THE CONE OF THE BEARING / TIBIAL INSERT. BEARING CHANGED. ORIGINAL SURGEON DR (B)(6). THE LPS PROCEDURE WAS A REVISION OF A PERIPROSTHETIC FRACTURE OF A FEMUR ASSOCIATED WITH A FEMORAL COMPONENT OF A TOTAL KNEE REPLACEMENT (NOT DEPUY SYNTHES PRODUCT).

  Patient problems: Insufficient Information

  MAUDE report 14103594 ↗
• InjuryApr 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO A DISLOCATION BECAUSE THE KNEE WAS TO TIGHT IN FLEXION CAUSING THE INSERT TO SEPARATE FROM THE TIBIAL COMPONENT. THE DOCTOR DECIDED TO CHANGE THE ADAPTOR FROM A 5 TO A 0 AND ALSO DECIDED TO REPLACE THE FEMUR AND INSERT AS WELL. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 14016530 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO (HO)HETEROTOPIC OSSIFICATION AND BECAME QUITE STIFF. FROZEN SECTION WAS NEGATIVE AND NO LABS INDICATED INFECTION. HO WAS REMOVED BUT PATIENT WAS STILL NOT A MOBILE AS THE SURGEON WOULD PREFER. FEMORAL SIDE WAS SHORTENED BY CHANGING FEMORAL COMPONENTS AND USING A 0 ADAPTER. THE NEW PIN, WHICH COMES WITH EVERY NEW DISTAL FEMUR WAS USED. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Extraskeletal ossification; Muscular Rigidity

  MAUDE report 13827175 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13169184 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN, MILD INSTABILITY AND LOOSENING OF THE PATELLA COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. PATELLA COMPONENT WAS REMOVED AND NOT REPLACED. A SIGNIFICANT AMOUNT OF SCAR TISSUE AND BONY FORMATION WAS ALSO REMOVED. AN INSERT ONE SIZE THICKER WAS ALSO PLACED ADDRESSING THE LAXITY NOTED. DOI: (B)(6) 2018, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity; Pain; Scar Tissue

  MAUDE report 12773554 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DOING WELL BUT DEVELOPED A UTI. SUBSEQUENTLY, HER KNEE BEGAN TO SWELL AND GET "HOT". SURGEON ASSUME ACUTE INFECTION SO MODULAR COMPONENTS WERE EXCHANGE ALONG WITH A THOROUGH I&D AND PLACEMENT OF ANTIBIOTIC BEADS. THE COMPONENTS REMOVED WERE NON CEMENTED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11843794 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY INSERT WAS REMOVED AND REPLACED WITH A NEW ONE. IRRIGATION AND DEBRIDEMENT PERFORMED BEFORE POLY REPLACEMENT. NO DELAYS DURING SURGERY. DOI: (B)(6) 2018 DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 11780001 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11771794 ↗
• InjuryMar 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO CONVERT TO A RIGHT KNEE ARTHRODESIS. PATIENT HAD A CHRONIC DISLOCATION PROBLEM. THE LPS INSERT WOULD COME UP OUT OF THE MBT REVISION TIBIAL COMPONENT. SURGEON AND PATIENT DECIDED TO DO A ARTHRODESIS. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 11553718 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11028104 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED DUE TO PAIN, SWELLING AND A WARM KNEE 4 DAYS POSTOPERATIVELY. SURGEON PERFORMED THOROUGH I&D, COMPONENT EXCHANGE AND PLACEMENT OF ANTIBIOTIC BEADS. ASPIRATION PRIOR TO SURGERY LED SURGEON TO BELIEVE IT WAS INFECTED. COMPONENTS WERE NOT INGROWN AS THEY HAD ONLY BEEN IN FOR 5 DAYS. LOOSENING DUE TO TIME IN THE BODY. IT TAKES APPROXIMATELY 6 WEEKS FOR IMPLANTS TO INGROW, THESE HAD 4-5 DAYS. THE WHOLE FEMUR WAS REPLACED TO INCLUDE THE PIN. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 10733816 ↗
• InjuryJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT BECAME INFECTED, SO IMPLANTS WERE REMOVED AND A ONE STAGE FUSION WAS IMPLANTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10323224 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN RELATED TO THE PATELLA. THE COMPETITOR PATELLA FROM HER PRIMARY KNEE HAD BEEN LEFT WHEN HER KNEE WAS REVISED AND WAS FOUND TO BE MALTRACKING. IT WAS REMOVED AND EXCHANGED FOR A SIGMA PATELLA AND TRACKING WAS SIGNIFICANTLY IMPROVED. A THICK INSERT WAS ALSO PLACED AS SOME LAXITY WAS NOTED WHILE TRIALING. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10271748 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ARTHROFIBROSIS, DEVELOPED SEVERE HO AND COULD NOT STRAIGHTEN HER LEG. A THOROUGH DEBRIDEMENT TO INCLUDE ALL HO AND ALL IMPLANTS WERE REMOVED THEN REPLACED. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Adhesion(s); Extraskeletal ossification; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10262437 ↗