FDA Adverse Event Injury Summary report: N

SUMMIT POR TAPER SZ6 STD OFF

MDR report key: 8784350 · Received July 12, 2019

Report

Report Number: 1818910-2019-98125
Event Type: Injury
Date Received: July 12, 2019
Date of Event: September 6, 2011
Report Date: October 31, 2012
Manufacturer: DEPUY ORTHOPAEDICS INC US
Product Code: LPH
UDI-DI: 10603295059370
PMA / PMN Number: K001991
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. ADDED STEM DUE TO THIS ALLEGATION. DOI: (B)(6) 2004, DOR: (B)(6) 2011, (LEFT HIP).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
577950	SUMMIT POR TAPER SZ6 STD OFF	SUMMIT HIP STEM : HIP FEMORAL STEM	LPH	DEPUY ORTHOPAEDICS INC US		YS9D31000	10603295059370

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Required Intervention