FDA Adverse Event Injury Summary report: N

ARCOS CON SZ A STD 50MM

MDR report key: 3973611 · Received August 1, 2014

Report

Report Number: 0001825034-2014-06709
Event Type: Injury
Date Received: August 1, 2014
Date of Event: July 8, 2014
Report Date: August 21, 2014
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWA
PMA / PMN Number: PK090757
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO AN UNKNOWN REASON; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2014 DUE TO INFECTION. DURING THE PROCEDURE, THE FEMORAL STEM WAS STUCK AND COULD NOT BE REMOVED. A 60 MINUTE DELAY OCCURRED DURING THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
450080	ARCOS CON SZ A STD 50MM	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	151280

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R