PHYSICA KR 6531.54.710Recalls & reported problems
Limacorporate SPA · PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #7 H. 10 mm Right · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390182690), received between Aug 21, 2025 and Aug 21, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Medical device site infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
KNEE REVISION SURGERY, PERFORMED ON (B)(6) 2025, DUE TO INFECTION. THE FOLLOWING COMPONENT WAS REMOVED: PHYSICA KR TIB. LINER RIGHT #7 (PART CODE 6531.54.710, LOT NUMBER 2110652, STERILIZATION (B)(4). AND REPLACED WITH THE FOLLOWING NEW ONE: PHYSICA KR TIB. LINER RIGHT #7 (PART CODE 6531.54.710, LOT NUMBER 2021282, STERILIZATION (B)(4). THE OTHER COMPONENTS PREVIOUSLY IMPLANTED WERE LEFT IN SITU: PHYSICA KR FEMUR COMP.RIGHT #8 (PART CODE 6511.09.180, LOT NUMBER 19AS0K9, STERILIZATION (B)(4). PHYSICA FIXED TIBIAL PLATE #7 (PART CODE 6522.15.070, LOT NUMBER 2221171, STERILIZATION (B)(4). PATELLAR PROSTHES.D.32 H.8.5MM (PART CODE 6595.54.032, LOT NUMBER 2021985, STERILIZATION (B)(4). PREVIOUS SURGERY PERFORMED ON (B)(6) 2023. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1954. THE EVENT HAPPENED IN THE UNITED STATES.
Patient problems: Medical device site infection
MAUDE report 22861640 ↗
Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 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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