FDA Adverse Event Injury Summary report: N

DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM

MDR report key: 3020924 · Received March 19, 2013

Report

Report Number
MW5029472
Event Type
Injury
Date Received
March 19, 2013
Report Date
March 19, 2013
Manufacturer
DEPUY ORTHOPAEDICS, INC.
Product Code
JDI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD A TOTAL LEFT HIP REPLACEMENT ON (B)(6) 2008. I RECEIVED THE DEPUY TOTAL HIP SYSTEM PINNACLE 100 ACETABULAR CUP SZ MM50. PRIOR TO SURGERY, I HAD PAIN IN THE GROIN AND BUTTOCK AND THAT DID AT TIMES RADIATE TO MY THIGH AND INTO THE BUTTOCK. AFTER SURGERY, THAT PAIN WENT AWAY, BUT THEN IN (B)(6) 2010, X-RAYS SHOWED METAL-ON-METAL ASSOCIATED EROSION AND POSSIBLE LOOSENING OF MY SOCKET ON THE LEFT TOTAL HIP DONE IN 2008. I HAD A HIP ASPIRATION DONE ON (B)(6) 2011 WHICH SHOWED YELLOW, SLIGHTLY TURBID JOINT FLUID. THERE WAS DETERIORATION OF THE BONE LEADING TO A TOTAL FAILURE OF THE JOINT. I HAD A REVISION OF MY LEFT TOTAL HIP REPLACEMENT ON (B)(6) 2011 REQUIRING ADDITIONAL HOSPITALIZATION. I THEN HAD DISCOMFORT AGAIN IN (B)(6) 2012 AND WAS TOLD THAT THE NEW CUP WAS LOOSE. I HAD DIFFICULTIES GETTING UP FROM A SEATED POSITION AND WALKING. I WAS ON CRUTCHES AS WELL. RADIOGRAPHS SHOWED LOOSENING OF THE LEFT ACETABULAR COMPONENT WITH MEDIAL BONE LOSS. I WAS TOLD THAT I HAD A MECHANICAL COMPLICATION OF THE INTERNAL ORTHOPEDIC DEVICE, IMPLANT AND GRAFT, AS WELL AS, A DISLOCATION OF THE PROSTHETIC JOINT. I WAS A CANDIDATE FOR EMERGENT REVISION SURGERY. I REQUIRED BONE GRAFTING AND WAS ON CRUTCHES AFTER THE SECOND REVISION FOR APPROXIMATELY SIX WEEKS. I WAS WARNED AGAINST THE RISK OF CONTINUOUS CUP LOOSENING. I HAD A LEFT REVISION OF THE ACETABULAR COMPONENT AND BONE GRAFTING DONE ON (B)(6) 2012. THERE WAS QUITE A BIT OF GREENISH FLUID IN THE JOINT AND QUITE A MEDIAL SUBLUXATION OF THE SOCKET. DATES OF USE: (B)(6) 2008 - (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: LEFT HIP OSTEOARTHROSIS. ON (B)(6) 2011 - VISITING NURSE. ON (B)(6) 2012 - PHYSICAL THERAPY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
114923 DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM HIP IMPLANT HOLE ELIMINATOR JDI DEPUY ORTHOPAEDICS, INC. 1246-03-000 C48AK1000
114924 DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM HIP IMPLANT CUP KWA DEPUY ORTHOPAEDICS, INC. 1217-01-050 CY6CA1000
114925 DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM HIP IMPLANT METAL INSERT KWY DEPUY ORTHOPAEDICS, INC. 1218-87-350 2733743
114926 DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM HIP IMPLANT FEMORAL HEAD KXA DEPUY ORTHOPAEDICS, INC. 1365-52-000 2717724
115065 DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM HIP IMPLANT CORAIL LZO DEPUY ORTHOPAEDICS, INC. 3L92801 2549726

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization| R| S