LPS 1987-27-221Recalls & reported problems
Depuy (Ireland) · LPS TIBIAL INSERT HINGE UNIVERSAL SMALL 21mm · Class 2 · Implant
All models of LPS (113)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295079521), received between Jun 14, 2018 and Apr 28, 2022 — classified as 4 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
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
Patient problems
- Unspecified Infection3
- Discomfort1
- Muscular Rigidity1
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS HAD KNEE DISCOMFORT AND KNEE STIFFNESS. IMPLANTS REMOVED AND WENT WITH A SMALLER FEMORAL COMPONENT AND THINNER POLY. ORIGINAL IMPLANT DATE UNKNOWN. BONE CEMENT WAS NOT INDICATED. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT SIDE.
Patient problems: Discomfort; Muscular Rigidity
MAUDE report 14237964 ↗InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS KNEE INFECTION. THE 21MM SMALL HINGE INSERT WAS REMOVED AND A NEW 21MM SMALL INSERT AND PIN WAS REPLACED. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9800222 ↗InjuryAug 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2018 FOR YET ANOTHER SURGERY. ALL IMPACTS WERE REMOVED FROM THE LEFT KNEE. MULTIPLE SPECIMENS WERE SENT TO THE LAB. A CEMENT SPACER WAS PLACED IN THE VOID CREATED BY IMPLANT REMOVAL. PATIENT MAY FACE A CHALLENGING DECISION AS TO NEXT PROCEDURE. SURGEON MENTIONED POSSIBILITY OF AKA. DOI: (B)(6) 2015; (B)(6) 2018, INSERT ONLY; DOR: (B)(6) 2018; LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 7778374 ↗InjuryJun 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT WAS REVISED TO ADDRESS CHRONIC INFECTION. POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2015; DOR: (B)(6) 2018; LEFT KNEE.
Patient problems: Not Applicable; Unspecified Infection
MAUDE report 7601992 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices
- ELEOS™ 25001208EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 deaths193 reports
- ELEOS™ THSMWRS01MOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER190 reports
- "UNITED" USTAR II Hip System 1115-1413United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls3 reports
- "UNITED" USTAR II Hip System 1115-1217United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1417United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1213United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/11WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/12WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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