FDA Adverse Event Injury Summary report: N

DEPUY PINNACLE ACETABULAR CUP SZ MM 50

MDR report key: 3062784 · Received April 11, 2013

Report

Report Number: MW5029767
Event Type: Injury
Date Received: April 11, 2013
Date of Event: March 10, 2009
Report Date: April 11, 2013
Manufacturer: DEPUY ORTHOPAEDICS, INC.
Product Code: KWA
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: CA, US
Reporter Occupation: PATIENT

Narratives

Description of Event or Problem · 1

I HAD A TOTAL HIP REPLACEMENT LEFT ON (B)(6) 2009. I REC'D THE DEPUY TOTAL HIP PINNACLE ACETABULAR CUP SZ MM50, S-ROM METAL ON METAL FEMORAL HEAD. PRIOR TO SURGERY I HAD GROIN AND THIGH PAIN WHICH DID NOT IMPROVE AND HAS INCREASED SINCE SURGERY. THE GRINDING AND POPPING GOT WORSE AND IN (B)(6) 2012 MY DOCTOR INFORMED ME IT MAY BE THE METAL-ON-METAL DEVICE. ON (B)(6) 2012, I UNDERWENT ANOTHER SURGERY TO HAVE THE DEVICE REMOVED. PHYSICAL THERAPY (B)(6) 2009.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot
154830	DEPUY PINNACLE ACETABULAR CUP SZ MM 50	METAL-ON-METAL HIP IMPLANT, ACETABULAR CUP	KWA	DEPUY ORTHOPAEDICS, INC.	1217-32-050	C91JD1000
154831	DEPUY S-ROM M METAL ON METAL FEMORAL HEAD, 36 MM	METAL-ON-METAL HIP IMPLANT, FEMORAL HEAD	KWA	DEPUY ORTHOPAEDICS, INC.		2587300
154832	DEPUY PINNACLE METAL INSERT	METAL-ON-METAL HIP IMPLANT, INSERT	KWA	DEPUY ORTHOAPAEDICS, INC.		2797854
154833	DEPUY PINNACLE CANCELLOUS BONE SCREW	CANCELLOUS BONE SCREW	HWC	DEPUY ORTHOPAEDICS, INC.		C4YK14000
154834	DEPUY PINNACLE CANCELLOUS BONE SCREW	CANCELLOUS BONE SCREW	HWC	DEPUY ORTHOPAEDICS, INC.		C99AM4000
154835	DEPUY S-ROM TOTAL HIP SYSTEM ZTT PROXIMAL SLEEVE	PROXIMAL SLEEVE	KWA	DEPUY ORTHOPAEDICS, INC.		2474920
154836	S-ROM TOTAL HIP SYSTEM FEMORAL STEM STANDARD	FEMORAL STEM	JDI	DEPUY ORTHOPAEDICS, INC.		2675441

Patients

Seq	Age	Sex	Outcome	Treatment
1	42 YR		Required Intervention\| S