FDA Adverse Event Injury Summary report: N

ASR ACETABULAR CUPS 58

MDR report key: 2254305 · Received September 19, 2011

Report

Report Number: 1818910-2011-18439
Event Type: Injury
Date Received: September 19, 2011
Report Date: August 22, 2011
Manufacturer: DEPUY INTERNATIONAL
Product Code: KWA
PMA / PMN Number: K040627
Removal / Correction Number: Z-1749/1816-2011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

PRELIMINARY DISCLOSURE FORM PROVIDED ADDITIONAL INFORMATION WHICH DOES NOT AFFECT THE OUTCOME OF THE INVESTIGATION. ADDITIONALLY, EMDR 1818910-2011-18440 IS A DUPLICATE OF THIS MEDWATCH AND HAS BEEN REJECTED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.

Additional Manufacturer Narrative · 1

CORRECTION: IN FOLLOW-UP 1 OF THIS EMDR, PLEASE DISREGARD STATEMENT THAT SAYS THERE IS A DUPLICATE OF THIS EMDR. THAT STATEMENT WAS MADE IN ERROR. THERE IS NOT A DUPLICATE OF THIS PARTICULAR EMDR. DEPUY CONSIDERS THE INVESTIGATION CLOSED.

Additional Manufacturer Narrative · 1

THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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.

Description of Event or Problem · 1

LITIGATION PAPERS ALLEGE THE PATIENT DEVELOPED PAINFUL AND DANGEROUS COMPLICATIONS, HAD TO UNDERGO AN UNNECESSARY AND PAINFUL REVISION SURGERY, AND WILL HAVE LIFELONG RESIDUAL PROBLEMS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ASR ACETABULAR CUPS 58	ACETABULAR CUP	KWA	DEPUY INTERNATIONAL		2205789

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention