FDA Adverse Event Injury Summary report: N

ASR ACETABULAR IMPLANT 56

MDR report key: 2884708 · Received December 24, 2012

Report

Report Number: 1818910-2012-29082
Event Type: Injury
Date Received: December 24, 2012
Date of Event: June 25, 2012
Report Date: March 6, 2014
Manufacturer: DEPUY INTERNATIONAL LTD. 8010379
Product Code: KWA
Removal / Correction Number: Z-1749/1816-2011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

Additional Manufacturer Narrative · 1

THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

Description of Event or Problem · 1

ASR REVISION; ASR HIP RESURFACING - RIGHT; REASON FOR REVISION: PAIN.

Description of Event or Problem · 1

NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION, ASR HIP RESURFACING - RIGHT, REASON(S) FOR REVISION: PAIN. BI-LATERAL - PLEASE SEE COM (B)(4) / (B)(4) FOR LEFT SIDE REVISION. UPDATE RECEIVED: (B)(6) 2014 - ADDED HOSPITAL: (B)(6) AND CROSS REFERENCED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ASR ACETABULAR IMPLANT 56	HIP ACETABULAR CUP	KWA	DEPUY INTERNATIONAL LTD. 8010379		2805321

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention