UNKNOWN

MDR report key: 3936243 · Received July 15, 2014

Report

Report Number: 0001825034-2014-06174
Event Type: Injury
Date Received: July 15, 2014
Report Date: October 18, 2014
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWA
PMA / PMN Number: PUNKNOWN
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 1825034-2014-08597 AND 08599.

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. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2009. DURING POST-OPERATIVE MONITORING, DISLOCATION WAS NOTED ON (B)(6) 2009. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. AN INVOICE HISTORY COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATE.

Description of Event or Problem · 1

AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2009. DURING POST-OPERATIVE MONITORING, DISLOCATION WAS NOTED ON (B)(6) 2009. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. AN INVOICE HISTORY COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
412820	UNKNOWN	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R