M2A-RINGLOC ACETABULAR LINER 28MM X SIZE 24 10 DEGREE

MDR report key: 2760080 · Received September 26, 2012

Report

Report Number: 0001825034-2012-01712
Event Type: Injury
Date Received: September 26, 2012
Date of Event: August 10, 2012
Report Date: August 28, 2012
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWA
PMA / PMN Number: PK002379
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EXAMINATION OF RETURNED DEVICE FOUND EVIDENCE OF IMPINGEMENT AND NO EVIDENCE OF PRODUCT NON-CONFORMANCE WAS FOUND.

Additional Manufacturer Narrative · 1

THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01711 / 01712). EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT PRIMARY TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO IMPINGEMENT OF FEMORAL NECK ON POSTERIOR EDGE OF LINER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	M2A-RINGLOC ACETABULAR LINER 28MM X SIZE 24 10 DEGREE	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	961120

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R