FDA Adverse Event Injury Summary report: N

CORAIL2 STD SIZE 8

MDR report key: 3813432 · Received May 15, 2014

Report

Report Number: 1818910-2014-18845
Event Type: Injury
Date Received: May 15, 2014
Date of Event: January 29, 2013
Report Date: May 1, 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

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

Additional Manufacturer Narrative · 1

NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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.

Description of Event or Problem · 1

FORMAL CLAIM RECEIVED REGARDING PINNACLE/CORAIL HIP IMPLANT REVISION. REPORTED PAIN AND SUBLUXING IN (B)(6) 2011. REVISION FOUND FIBROCOLLAGENOUS TISSUE SHOWING FEATURES OF METALLOSIS AND MILD ALVAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
290625	CORAIL2 STD SIZE 8	HIP FEMORAL STEM/SLEEVE	KWA	DEPUY FRANCE SAS REG. # 3003895575		1973117

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Other