FDA Adverse Event Injury Summary report: N

PHYSICA

MDR report key: 24603382 · Received March 16, 2026

Report

Report Number: 3008021110-2026-00142
Event Type: Injury
Date Received: March 16, 2026
Date of Event: April 6, 2022
Report Date: March 16, 2026
Manufacturer: LIMACORPORATE S.P.A
Product Code: JWH
UDI-DI: 08033390088954
PMA / PMN Number: K141934
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

REVIEW OF MANUFACTURING AND STERILIZATION RECORDS DID NOT HIGHLIFHT ANY PRE-EXISTING ANOMALY OR NON CONFORMITY THAT COULD HAVE CONTRIBUTED TO REPORTED ISSUE.THE MANUFACTURER WILL PROVIDE A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

Description of Event or Problem · 0

REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO RESTORE KNEE FUNCTIONALITY AFTER REMOVAL OF TIBIAL LINER. ORIGINAL SURGERY OCCURRED ON (B)(6) 2018 TO IMPLANT PHYSICA KR KNEE SYSTEM CONSISTING OF FOLLOWING COMPONENTS: - PHYSICA KR FEMUR COMP.RIGHT #8 (PART NUMBER 6511.09.180, LOT 16AS039, STERILIZATION (B)(4)), - PHYSICA FIXED TIBIAL PLATE #7 (PART NUMBER 6522.15.070, LOT 1801260, STERILIZATION (B)(4)), - PHYSICA KR TIB. LINER RIGHT #7 (PART NUMBER 6531.50.714, LOT 14L0090, STERILIZATION (B)(4)). PATIENT STARTED TO HAVE BURSITIS, AND AT A FOLLOW-UP APPOINTMENT STATED SHE WAS FALLING BECAUSE OF HER KNEE AND CONTINUED PAIN. INITIALLY SHE TRIED PHYSICAL THERAPY AND A KNEE BRACE BUT CONTINUED TO HAVE FALLS AND PAIN. X-RAY SCAN DID NOT SHOW LOOSENING ACCORDING TO MEDICAL TEAM. ABOVE MENTIONED LINER WAS EXPLANTED ON (B)(6) 2021. PATIENT IS FEMALE. THE EVENT OCCURRED IN THE UNITED STATES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
663219	PHYSICA	KR LINER RIGHT #7 - H. 14	JWH	LIMACORPORATE S.P.A	6531.50.714	14L0090	08033390088954

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female	Required Intervention