MAUDE Adverse Event Report: ZIMMER, INC.. VERSYS IMP SYSTEM; PROSTHESIS, HIP SEMI CONSTRAINED METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 7659-08

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)

Event Date 06/02/2015

Event Type  Injury  

Event Description

Pt id: (b)(6); on b)(6) 2005, he underwent a complex left total hip arthroplasty with removal of existing acetabular hardware, which had been placed for a severe acetabular fracture post motor vehicle accident in 2004.His acetabular fracture was complicated by radiation-related wound necrosis and enterococcus deep infection and also by persistent peroneal nerve and hip abductor palsies.Due to history of infection, the decision was made to completely remove the acetabular fixation hardware and to use cemented components with antibiotic loaded cement.The implant used was a zimmer versys heritage hip prosthesis, cemented 12/14 neck taper, standard offset neck, 125mm stem length size 12 zimaloy co-cr mo, lot #60213924, cat #7857-12; versys hip system distal centralizer 9mm oo assemble w/bone cement pmma sterile lot# 60227991, cat #7659-08, versys hip system femoral head 12/14 taper 32mm dia +0 mm neck length zimaloy co-cr-mo, lot#60246933, cat #8018-32-02, howmedica / osteonics 65c-3254 trident polyethylene acetabular cup, howmedica x-change bio mesh large; bonesource bvf, simplex p with tobramycin antibiotic bone cement times 2 cat# 6197-9-001, control # mjl021.This was a complex primary total hip arthroplasty with a transtrochanteric approach for sloof acetabular acetabular reconstruction and the all-polyethylene socket was cemented in.In (b)(6) of 2014, he noticed sudden increasing pain and shortening of the left limb by about 2 inches.Plain x-rays showed acetabular failure.On (b)(6) 2015, his urine cobalt level was 5.0mcg/l.On (b)(6) 2015, the left tha was revised to an all poly longevity zca socket 32/59 inner / outer diameter, simplex single batch with 1 gram of vancomycin bowl mix, 100cc frozen allograft bone with 1 gram vancomycin, zimmer tm augment 60mm diameter by 20mm thickness with 2 screws, exeter 44#0 stem with 2 batch simplex with 2 grams vancomycin, and a delta ceramic 32mm +4 head.The acetabulum had severe superior bone deficiency and moderate anterior deficiency.The acetabular implants were grossly loose and showed moderate eccentric polyethylene wear.The femoral stem was fixed.The cement mantle was intact but was stained with metallic debris indicating likely corrosion or wear at the stem cement interface despite the stem being well-fixed.The modular stem head interface had no evidence of corrosion.Frozen section of hip tissue was sent to pathological analysis and was described as fibrotic tissue containing bone fragments and focal areas of metallosis compatible with reaction to prosthesis and negative for infection.On (b)(6) 2015, he sustained a lateral dislocation of the left hip related to abductor insufficiency.This was reduced in the emergency room.Fda safety report id# (b)(4).

• Brand Name: VERSYS IMP SYSTEM
• Type of Device: PROSTHESIS, HIP SEMI CONSTRAINED METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): ZIMMER, INC..
• MDR Report Key: 9686760
• MDR Text Key: 178574266
• Report Number: MW5092862
• Device Sequence Number: 3
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2020
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 7659-08
• Device Lot Number: 60227991
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 94