FDA Adverse Event Injury Summary report: N

OSS POLY LOCK PIN

MDR report key: 3892263 · Received June 24, 2014

Report

Report Number: 0001825034-2014-05749
Event Type: Injury
Date Received: June 24, 2014
Date of Event: June 2, 2014
Report Date: June 3, 2014
Manufacturer: BIOMET ORTHOPEDICS
Product Code: JDI
PMA / PMN Number: PK002757
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE IMPLANTED - UNKNOWN. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION." THIS REPORT IS NUMBER 2 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05748/05753).

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO INFECTION. DURING THE PROCEDURE, THE COMPONENTS WERE WASHED AND THE TIBIAL BEARING WAS REMOVED AND REPLACED. IT WAS NOTED THAT THE TIBIAL BEARING HAD A FRACTURE THROUGH THE SURFACE OF THE COMPONENT. AN INVOICE HISTORY COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
369286	OSS POLY LOCK PIN	PROSTHESIS, KNEE	JDI	BIOMET ORTHOPEDICS	N/A	141290

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R