MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALL POLY CUP-CROSSFIRE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	65C-3254
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	06/18/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: trident all poly cup-crossfire; cat# 65c-3254; lot# unknown.Unknown_cork_product; cat# unk_shc; lot# unknown.Simplex with tobramycin 1 pack; cat# 6197-9-001; lot # unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
This pi is for revision 1 on 2015.It was reported through a medwatch report (mw5092862) "on 2005, he underwent a complex left hip 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 hip prosthesis, cemented 12/14 neck taper, standard offset neck, 125mm stem length size 12 cocr mo, ; distal centralizer 9mm oo assemble w/ bone cement pmma sterile, hip system femoral head 12/14 taper 32mm dia +0 mm neck length cocr-mo, 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.This was a complex primary total hip arthroplasty with a transtrochanteric approach for sloof acetabular reconstruction and the all-polyethylene socket was cemented in.In [.] of 2014, he noticed increasing pain and shortening of the left limb by about 2 inches.Plain x-rays showed acetabular failure.On [.] 2015, his urine cobalt level was 5.0mcg/l.On [.] 2015, the left tha was revised to and 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, 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 acetabular 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 pathology 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 [.] 2015, he sustained a lateral dislocation of the left hip related to abductor insufficiency.This was reduced in the emergency room.".

• Brand Name: TRIDENT ALL POLY CUP-CROSSFIRE
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9913499
• Report Number: 0002249697-2020-00664
• Device Sequence Number: 3131541
• Product Code: JDI
• UDI-Device Identifier: 07613327024234
• UDI-Public: 07613327024234
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K012026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 65C-3254
• Device Catalogue Number: 65C-3254
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention