LPS 1987-07-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295078548), received between Sep 15, 2017 and Apr 24, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  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: (B)(6) 2018. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24979341 ↗
• 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 24690981 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUES TO BE INFECTED. THE SPACER AND ALL CEMENT ARE REMOVED. A THOROUGH I&D IS PERFORMED AND A NEW SPACER IS FASHIONED UTILIZING LPS COMPONENTS. NO PATIENT HARM NOR DELAY WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23477259 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO DRAIN AFTER HER PROCEDURE. LABS LOOK GOOD AND ASPIRATION IS NEGATIVE FOR INFECTION. SURGEON BELIEVES THE ANTIBIOTICS PLACED A THE TIME OF SURGERY ARE CAUSING THE DRAINAGE, SO HE CHOSE TO REMOVE ALL COMPONENTS AND PLACE NEW ONES. NO DELAY NOR PATIENT HARM IS NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THEY WERE FUNCTIONING AS EXPECTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 22441259 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2024, DOR: (B)(6) 2025 , AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21530240 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DRAINING, SURGEON ELECTED TO WASHOUT AND CHANGE MODULAR PARTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 20353123 ↗
• InjuryAug 22, 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 OR 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: (B)(6) 2024. DOE: (B)(6) 2024.

  Patient problems: Fluid Discharge

  MAUDE report 20028142 ↗
• InjuryAug 20, 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 OR 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: (B)(6) 2024. DOE: (B)(6) 2024.

  Patient problems: Fluid Discharge

  MAUDE report 20004062 ↗
• 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 19191566 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. A. WAS THERE LOOSENING INVOLVED IN THE EVENT? IF YES, PLEASE PROVIDE THE LOOSENING COMPONENT'S. YES, AND AS STATED IN THE DER. THERE WAS LOOSENING AT BOTH THE BONE/SLEEVE. AND BONE/STEM INTERFACE MIST LIKELY, DUE TO METALLOSIS FROM AN EXISTING FEMORAL SIDE PLATE. B. PLEASE CONFIRM, IF THERE WAS FRACTURE OF THE DISTAL FEMUR. NO, THERE WAS NO FRACTURE.

  Patient problems: Foreign Body Reaction; Unspecified Tissue Injury

  MAUDE report 17396290 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUED TO DRAIN. ALL COMPONENTS WERE REMOVED AND REPLACED IN A SINGLE STAGE REVISION UTILIZING A DUAL SET UP. THE CEMENT WAS A DEPUY PRODUCT BUT THE INFORMATION WAS NOT AVAILABLE AS IT WAS A HOSPITAL OWNED INVENTORY AND NOT ON THE PAPERWORK. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 13168157 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH A DRAINING WOUND. SURGEON SUSPECTS INFECTION AND FINDS PUSS IN THE KNEE. SURGEON PERFORMS A ONE STAGE KNEE REVISION WITH A DUAL SET UP AND PLACEMENT OF ANTIBIOTIC BEADS. TWO SURGERY DATES RELATE TO THIS DER AS A POLY EXCHANGE WAS PERFORMED ON (B)(6) 2021 WHERE A DER WAS SUBMITTED. CEMENT UTILIZED WAS A DEPUY PRODUCT, HOWEVER PART AND LOT INFO ARE UNAVAILABLE AS IT IS HOSPITAL OWNED AND NOT ON A PAPERWORK. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 12923000 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTED LPS STEM AT FEMUR HAS BEEN BROKEN. THE X-RAY SHOWED THAT THE IMPLANT AND BONE BOTH FRACTURED. DOR: (B)(6) 2021.

  Patient problems: Limb Fracture

  MAUDE report 12318706 ↗
• InjurySep 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6868479 ↗
• InjurySep 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6868410 ↗