LPS 1987-27-212Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295079484), received between Sep 18, 2017 and Jun 10, 2026 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE WAS INFECTED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25461495 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF SROM HINGE POLY AND HINGE PIN FOR ARTHFIBROSIS AND QUESTIONING IF INFECTION.

  Patient problems: Adhesion(s); Unspecified Infection

  MAUDE report 17867453 ↗
• MalfunctionNov 4, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  ACCORDING TO THE DISTRIBUTOR: REVISION TOTAL KNEE ARTHROPLASTY (S-ROM-MBT) WAS PERFORMED. WHEN INSTALLING THE LINER, THE DOCTORS FOUND THAT THE INNER METAL PART WAS NOT FIXED IN THE LINER, SO IT WAS IMPOSSIBLE TO INSTALL IT. THE PATIENT SUFFERED BECAUSE IT BECAME NECESSARY TO INSTALL A LARGER LINER (14MM), BECAUSE. THE LINERS WERE IN A SINGLE SIZE, THERE WAS A DELAY IN THE OPERATION. PRODUCT PHOTO: ATTACHED.

  Patient problems: Insufficient Information

  MAUDE report 15734902 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT FOR INFECTION. LPS INSERT EXCHANGE PACKAGE WAS MISSING THE HINGE PIN. HAD TO OPEN AN EXTRA HINGE PIN FOR THE CASE. DOI: (B)(6) 2020, DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 15475592 ↗
• MalfunctionSep 12, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE INSERT EXCHANGE PACKAGE WAS MISSING THE HINGE PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402303 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION. DOI: (B)(6) 2018, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12597704 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE JOINT INFECTION. DOI:(B)(6) 2017 DOR: (B)(6) 2021 UNKNOWN KNEE SIDE.

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

  MAUDE report 11879410 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FLEXION AND EXTENSION HAD DECREASED. PATIENT HAS LEFT SROM TKA. SURGEON REMOVED SCAR TISSUE, REPLACED POLY AND HINGE PIN WITH NEW COMPONENTS. DOI: (B)(6) 2017 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 11568590 ↗
• InjuryOct 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  CHANGE OF LPS SMALL INSERT. EVEN THOUGH THE INSERT SEEMS NOT BROKEN, THERE IS A INTERNAL "SHIFT BETWEEN POLY AND" HINGE PART.

  Patient problems: Inflammation; No Code Available; Pain

  MAUDE report 10747593 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONFIRMED NO MALPOSITIONING OF AN IMPLANTED DEPUY PRODUCT. IMPLANT WAS WELL ALIGNED; HOWEVER THE HINGE BEARING WAS NO LONGER ROTATING DUE TO OSTEOPHYTES/HETEROTOPIC BONE FORMATION. SALES REP ALSO MENTIONED THAT HINGE PIN WAS REMOVED, FEMUR AND TIBIAL COMPONENTS PRESERVED AND A NEW INSERT/OLD PIN USED. LEFT SIDE WAS THE AFFECTED SIDE IN THIS EVENT. OLD HINGE PIN REMOVED AND REUSED WITH NEW INSERT. SURGEON WAS ENCOURAGED TO USE NEW PIN BUT FELT THE OLD ONE WAS IN PERFECT CONDITION AND NO SIGN OF INFECTION.

  Patient problems: Edema; Extraskeletal ossification; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10663048 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8050881 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. THEY DID A POLY SWAP. DOI: (B)(6) 2017: DOR: (B)(6) 2017 LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7205817 ↗
• InjurySep 18, 2017Material Separation; Material Separation

  CUSTOMER REPORTED TO (B)(6): IMPLANTATION OF KNEE-TEP LEFT SIDE ON (B)(6) 2017. REVISION ON (B)(6) 2017 BECAUSE OF PATELLA LUXATION/SUBLUXATION. AS PER SURGERY REPORT DATED (B)(6) 2017: "¿PATELLA IS CENTERED. THE PROTHESIS ITSELF IS WELL FIXED IN THE BONE. INSPECTION OF INLAY SHOWS THAT THE AXIS IS DISCONNECTED FROM PE-INLAY. SO THE ROTATION OF FEMUR IS FREE; INLAY DOES NOT PARTICIPATE ROTATION."

  Patient problems: No Information

  MAUDE report 6871947 ↗