FDA Adverse Event Injury Summary report: N

UNKNOWN DEPUY 4MM AUGMENTS (UNKNOWN QUANTITY)

MDR report key: 3033364 · Received April 3, 2013

Report

Report Number: 1818910-2013-14837
Event Type: Injury
Date Received: April 3, 2013
Date of Event: September 19, 2012
Report Date: March 4, 2013
Manufacturer: 1818910 DEPUY ORTHOPAEDICS, INC.
Product Code: JWH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN

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

THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE ROOT CAUSE OF THE REPORTED EVENT; HOWEVER, PROVIDED MEDICAL RECORDS SUGGEST PATIENT TRAUMA FOUR DAYS POST-PRIMARY SURGERY WAS A POSSIBLE CONTRIBUTING FACTOR. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE OR PRODUCT ERROR AS A CONTRIBUTING FACTOR, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

Description of Event or Problem · 1

PATIENT CONTACTED DEPUY STATING THEY ARE EXPERIENCING KNEE PAIN AND BUCKLING. MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED DUE TO PAIN AND A RUPTURED MEDICAL CRUCIATE LIGAMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
136067	UNKNOWN DEPUY 4MM AUGMENTS (UNKNOWN QUANTITY)	AUGMENTS	JWH	1818910 DEPUY ORTHOPAEDICS, INC.		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Required Intervention