FDA Adverse Event Injury Summary report: N

LCS COMP RP INSERT STD 15MM

MDR report key: 3800794 · Received May 8, 2014

Report

Report Number: 1818910-2014-18384
Event Type: Injury
Date Received: May 8, 2014
Date of Event: April 16, 2014
Report Date: April 16, 2014
Manufacturer: DEPUY-RAYNHAM 1219655
Product Code: NJL
PMA / PMN Number: PP830055
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

PATIENT WAS REVISED TO ADDRESS UNDERSIZED IMPLANT. IT WAS REPORTED THAT THE PATIENT FELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
279319	LCS COMP RP INSERT STD 15MM	KNEE TIBIAL BEARING/INSERT	NJL	DEPUY-RAYNHAM 1219655		DC4E44000

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Required Intervention