FDA Adverse Event Injury Summary report: N

DLT TS CER HD 12/14 40MM +1.5

MDR report key: 4365934 · Received December 29, 2014

Report

Report Number: 1818910-2014-35224
Event Type: Injury
Date Received: December 29, 2014
Date of Event: December 3, 2014
Report Date: December 3, 2014
Manufacturer: DEPUY IRELAND 9616671
Product Code: LZO
PMA / PMN Number: PK071830
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SC, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

Additional Manufacturer Narrative · 1

NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 486261 AND 7840033. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ONE ADDITIONAL REPORTED INCIDENT AGAINST LOT CODE BS5CEA SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. 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

PATIENT WAS REVISED TO ADDRESS A MALPOSITIONED CUP AND CHRONIC DISLOCATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
853633	DLT TS CER HD 12/14 40MM +1.5	HIP FEMORAL HEAD	LZO	DEPUY IRELAND 9616671		7840033

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Required Intervention