LPS 1987-27-123Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295079446), received between Jun 22, 2017 and Nov 5, 2024 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 20614532 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPTIC KNEE. THE LPS POLY & LPS DISTAL FEMORAL COMPONENT WERE REMOVED. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D). IMPLANTED NEW LPS POLY X-SMALL 23 MM & LPS X-SMALL DISTAL FEMORAL COMPONENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17669700 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO SEPTIC RIGHT KNEE. LPS POLY & LPS DISTAL FEMORAL COMPONENT WERE REMOVED. AN I&D WAS PERFORMED IN THE (B)(6) 2023 PROCEDURE FOR THE PURPOSE OF TREATING A SEPTIC KNEE. IMPLANTED NEW LPS POLY X-SMALL 23MM & LPS RIGHT X- SMALL DISTAL FEMORAL COMPONENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17662527 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16598070 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRA-OP EVENT OF SIGNIFICANT BLEEDING AT THE POSTEROLATERAL SIDE FROM THE POPLITEAL ARTERY AND THIS BLEEDING WAS STOPPED BY PACKING AND THE USE OF VASCULAR CLIPS, TOTAL BLOOD LOSS WAS 500 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13558736 ↗
• MalfunctionApr 8, 2021Fracture; Fracture

  THE PLASTIC S-ROM/LPS INSERT BROKE IN TWO PIECES WHEN IMPACTING AT SURGERY. NO HARD INSTRUMENTS WAS USED. INSERTS WAS PUTTING IN RIGHT POSITION AND DURING EXAMINATION OF FLEXION/EXTENSION ROM SURGEON SAW THE METAL PART WAS LIFTING A BIT FROM THE PLASTIC PART. THEY WERE SUPPOSED TO USE INSERT XS 23 MM BUT SINCE THEY JUST HAD ONE OF EACH THEY HAD TO USE AN INSERT 21 MM. SURGERY DELAY 5 MINUTES. PROCEDURE SUCCESSFULLY COMPLETED NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633960 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE: RIGHT.

  Patient problems: Fall; Joint Laxity

  MAUDE report 11012488 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DO NOT HAVE PART NUMBERS FOR IMPLANTS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED. DOI: (B)(6) 2017 DOR: (B)(6) 2020 RIGHT KNEE

  Patient problems: No Code Available; Pain

  MAUDE report 10190822 ↗
• InjuryJan 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON DID AN I&D AND CHANGED THE POLY AND HINGE PIN. DOI: UNKNOWN. DOR: (B)(6) 2017. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7205224 ↗
• InjuryDec 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  POLY SWAP FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7078088 ↗
• 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 6868581 ↗
• InjuryJul 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION, HAD I&D AND POLY EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 6736406 ↗
• InjuryJun 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PERI PROSTHETIC FRACTURE. SURGEON IS NOT AWARE OF ORIGINAL KNEE SURGERY, OR LOCATION. UPDATE JUN 22, 2017: SALES REP WAS CALLED AND THE PERI-PROSTHETIC FRACTURE WAS PLATED 6 MONTHS PRIOR. IT'S UNKNOWN WHERE THE FRACTURE WAS EXACTLY (LPS STEM OR UNK HIP). THE BRAND OF HIP IMPLANTED IS UNKNOWN. AT THIS TIME A COMPLAINT WILL NOT BE CREATED FOR THE FRACTURE AS ITS UNKNOWN IF DEPUY PRODUCTS WERE INVOLVED. THE PATIENT WAS IN (B)(6). -FELT PAIN AND WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2017 FOR INFECTION AND THE INSERT WAS EXCHANGED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 6661873 ↗