LPS 1987-07-035Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295078531), received between Dec 7, 2017 and Sep 16, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient presents with well fixed and positioned implants post full patellar allograft placement due to quadriceps rupture after revision TKA. Graft is incorporated and patella is in an appropriate position, however the proximal portion of the allograft has become lax. A longer segment is utilized to increase tension and patellar tracking is quite good. A shortening of the proximal tissues is performed and reinforced. A long leg cast is placed to protect the repair post operatively. No allegation is made against the components. No delay nor patient harm is noted. When removing the segment to lengthen the construct, the adapter was removed from the sleeve. There is no record of this device in optimize so not lot information is available.DOI: (b)(6)2025.DOR: (b)(6)2026.Affected Side: Right.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 50788380 ↗
• InjuryMar 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT PRESENTED WITH AN LPS STATIC SPACER POST INFECTION THAT HAD DISASSOCIATED. THIS IS AN UNUSUAL OCCURRENCE AS SURGEON UTILIZES THESE COMPONENTS REGULARLY FOR THIS INDICATION. INFECTION HAS CLEARED AND SEGMENTS AND COMPONENTS ON TIBIAL SIDE WERE REMOVED TO PLACE AN LPS DISTAL FEMORAL REVISION TKA. ALL COMPONENTS WERE WELL FIXED. CEMENT UTILIZED FOR THE SPACER WAS HOSPITAL OWNED SO NO LOT NOR QUANTITY INFORMATION IS AVAILABLE IN OUT RECORDS. NO DELAY NOR PATIENT HARM WAS NOTED. DOI: (B)(6) 2026. DOR: (B)(6) 2026 AFFECTED SIDE-RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690951 ↗
• 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 21549798 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS WITH A DISLOCATED DISTAL FEMORAL COMPONENT. PATIENT APPEARS TO HAVE STRETCHED OUT THE SURROUNDING SOFT TISSUES, SPECIFICALLY HIS EXTENSOR MECHANISM AS HE HAD A STATIC SPACER PRIOR. JOINT LINE IS ADJUSTED UTILIZING LPS COMPONENTS AND A THICKER INSERT. MULTIPLE FROZEN SECTIONS AND CULTURES WERE SENT OPERATIVELY AND THE AREA DISTAL SHOWED POSSIBLE INFECTION. A THOROUGH IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED AND PLACEMENT OF NEW COMPONENTS AND ANTIBIOTIC BEADS WERE PLACED. THERE WAS NO DELAY NOR PATIENT HARM. DOI- (B)(6) 2024, DOR- (B)(6) 2024, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20226177 ↗
• 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) 20024. DOE: ON (B)(6) 2024.

  Patient problems: Fluid Discharge

  MAUDE report 20022994 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM. SURGEON INTENTIONALLY SHORTENED HER FEMORAL CONSTRUCT WHEN DOING SO TO ALLOW FOR INCREASED FLEXION. PATIENT FELT UNSTABLE AND WAS BROUGHT TO THE OR FOR INCREASED LENGTH. COMPONENTS WERE EXCHANGED WITHOUT DELAY OR PATIENT HARM. THERE ARE NO ALLEGATIONS AGAINST ANY COMPONENTS, ONLY FILING DUE TO THE EXCHANGE OF COMPONENTS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19906733 ↗
• 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 19191591 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE CONFIRM WAS THE INFECTION CLEARED. -UNKNOWN. LITTLE TO NO WAY TO CONFIRM OR RULE OUT INFECTION DURING A PROCEDURE. TISSUES LOOKED GOOD AT THE TIME OF SURGERY, HOWEVER, DUE TO PREVIOUS CONFIRMED INFECTION, IT WAS TREATED AS IF STILL INFECTED. B. WAS THE STEM LOOSE AS WELL? WHICH SLEEVE WAS LOOSE? -FEMORAL STEM WAS ALSO LOOSE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18517759 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IRRIGATION AND DEBRIDEMENT DONE FOR INFECTION WITH REPLACEMENT OF MODULAR COMPONENTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18088469 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS PERSISTENT BLOODY EFFUSION SINCE LAST SURGERY. SURGEON CHOOSES SURGICAL EXPLORATION AND I&D AS TREATMENT. LITTLE IS FOUND AND FROZEN SECTIONS ARE NEGATIVE. PATIENT DOES "OOZE" BUT NOT BLEEDERS FOUND. SURGEON NOTES MOTION LESS THAN HE WOULD PREFER AND CHOOSES TO REDUCE THE FEMORAL LENGTH BY CHANGING SEGMENTS. NO PATIENT HARM WAS NOTED. DOI: ON (B)(6) 2022. DOR:ON (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Swelling/ Edema

  MAUDE report 16231975 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT COMES INTO EMERGENCY ROOM AND WITH PAIN AND NOT FEELING WELL. XRAYS SHOW HETEROTOPIC BONE FORMATION AND WHAT APPEARS TO BE GAS IN TISSUES SURROUNDING THE IMPLANT, SIGNIFYING INFECTION. ONCE OPENED, GROSS PUS WAS NOTED CONFIRMING INFECTION. A THOROUGH I&D WITH REMOVAL OF HETEROTOPIC BONE, EXCHANGE OF COMPONENTS, PLACEMENT OF ANTIBIOTIC BEADS AND COATING OF PROSTHESES WITH HIGH DOSE ANTIBIOTIC CEMENT IS PERFORMED. CEMENT WAS LIKELY GMV WITH GENT BUT WOULD HAVE BEEN HOSPITAL OWNED SO NO LOT INFO OR CONFIRMATION IS AVAILABLE IN MY RECORDS. NO PATIENT HARM OCCURRED. THIS PATIENT DOES HAVE MULTIPLE SIGNIFICANT COMORBIDITIES WHICH MAKE HER MORE PRONE TO INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Extraskeletal ossification; Pain; Unspecified Infection

  MAUDE report 16195595 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DVT IN HER ARM FROM A PIC LINE POST OPERATIVELY. SHE WAS ANTICOAGULATED AND CAUSED A SWELLING IN HER KNEE. INCISION UNFORTUNATELY CAME OPEN DUE TO INCREASED SWELLING AND AN ID WAS PERFORMED. SURGEON CHOSE TO EXCHANGE MODULAR COMPONENTS AT THE TIME OF SURGERY. NO PATIENT HARM OCCURRED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Wound Dehiscence

  MAUDE report 15804085 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CONTRIBUTING FACTOR OF THE PATIENT'S LOSS IN QUAD CONTROL IS RELATED TO A NON-SPECIFIC NERVE ISSUE. THE ENTIRE FEMUR HAD BEEN DESECRATED, BUT THE JOINT LINE WAS RESTORED WITH A TOTAL FEMORAL IMPLANT.

  Patient problems: Joint Laxity; Nerve Damage; Unspecified Tissue Injury

  MAUDE report 12968395 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED PAIN, ABNORMAL RADIOGRAPHIC EVALUATION INDICATING INTERVAL MIGRATION ANTERIOR CORTEX ABUTMENT OF THE PROXIMAL STEM OF THE FEMORAL COMPONENT. THIS IS NOTED TO POTENTIALLY CAUSE A FUTURE FRACTURE. NO FRACTURE IS INDICATED CURRENTLY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DOI: (B)(6) 2011. DOE: (B)(6) 2018, (RIGHT KNEE).

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 12533130 ↗
• 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 11771796 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS REMOVED WERE INSERTED ON (B)(6) 2021. DER HAVE BEEN SUBMITTED ON EACH OF THESE DATES WITH RESPECTIVE CHANGES. ULTIMATELY THE GRAFT THAT WAS PLACED IN THE PATIENT BECAME INFECTED AND ALL IMPLANTS WERE REMOVED. ANTIBIOTIC BEADS AND A SPACER WAS PLACED IN THE PATIENT. NO DELAY TO SURGERY REPORTED. DOI: (B)(6) 2021 (TIBIAL TRAY, TIBIAL STEM, TIBIAL SLEEVE, AND CONTROL CABLE), DOI: (B)(6) 2021 (DISTAL FEMORAL COMPONENT, AND FEMORAL STEM), DOI: (B)(6) 2021 (FEMORAL SEGMENTAL COMPONENTS, AND TIBIAL INSERT), DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11602861 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD WOUND DEHISCENCE. THE SURGEON PERFORMED A THOROUGH I&D WITH COMPONENT EXCHANGE. DOI: (B)(6) 2020. DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 10830207 ↗
• 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 10733819 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT THE UNKNOWN INTERFACE. FEMORAL COMPONENT AND INSERT WERE REMOVED. WASHED PATIENT OUT AND TRIM PLANTED. DOI: (B)(6) 2019. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10379080 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON HAD TO DO A QUADRICEPS REPAIR AND WANTED TO SHORTEN THE IMPLANTS. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10153666 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SPACER PLACED LAST SEPTEMBER. HE CAME IN WITH INCREASED PAIN AND ELEVATED LABS. BROUGHT TO OR FOR I&D AND POSSIBLE COMPONENT CHANGE. SEGMENTS WERE EXCHANGED AND SLEEVE AND STEM WERE WELL FIXED AN LEFT IN PLACE. A THOROUGH DEBRIDEMENT WAS PERFORMED AS WELL AS PLACEMENT OF ANTIBIOTIC BEADS AND CEMENT. DOI: (B)(6) 2019. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10134215 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HETEROTOPIC OSSIFICATION. A THOROUGH I&D WAS PERFORMED WITH REMOVAL OF HETEROTOPIC OSSIFICATION AND PLACEMENT OF ANTIBIOTIC CEMENT AND BEADS. THE PATIENT IS STILL DRAINING. MODULAR COMPONENTS WERE EXCHANGED, STEMS WERE WELL FIXED AND WERE LEFT IN PLACE. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Extraskeletal ossification; Fluid Discharge; No Code Available; Unspecified Infection

  MAUDE report 10049236 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED LPS REVISION KNEE. SURGEON REMOVED THE SEGMENTS AND DISTAL FEMUR AND REPLACED WITH SIMILAR PARTS TO WHAT THEY TOOK OUT EXCEPT FOR A 5MM LONGER SEGEMENT. SURGEON WASHED OUT EXTENSIVELY THE DISTAL FEMUR REGION OF THE LEG. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9383232 ↗
• InjuryDec 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTED LEFT HIP WITH DRAINING SINUS TRACT. IRRIGATION AND DEBRIDEMENT AND EXCHANGE OF COMPONENTS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 7095261 ↗