FDA Adverse Event Injury Summary report: N

CORAIL AMT COLLAR SIZE 13

MDR report key: 3870553 · Received June 12, 2014

Report

Report Number: 1818910-2014-20909
Event Type: Injury
Date Received: June 12, 2014
Date of Event: May 21, 2014
Report Date: May 21, 2014
Manufacturer: DEPUY FRANCE SAS REG. # 3003895575
Product Code: KWA
PMA / PMN Number: PK042992
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FOUND OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS FOR THE ARTICULEZE M HEAD 36MM -2. PER WI-3430 A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE HEAD AND LINER IS NO LONGER REQUIRED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED COMPLAINTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

Additional Manufacturer Narrative · 1

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

Description of Event or Problem · 1

FORMAL CLAIM RECEIVED REGARDING PINNACLE/CORAIL HIP IMPLANTS. NO CONFIRMATION OF REVISION, OR REASON FOR REVISION, RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
348493	CORAIL AMT COLLAR SIZE 13	HIP FEMORAL STEM/SLEEVE	KWA	DEPUY FRANCE SAS REG. # 3003895575		1763067

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Other