MAUDE Adverse Event Report: STRYKER / HOWMEDICA OSTEONICS CORP. CROSSFIRE POLYETHYLENE INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYER, UNCEMENTED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Inflammation (1932); Swelling (2091); Toxicity (2333); Joint Dislocation (2374); Shaking/Tremors (2515)

Event Date 06/08/2016

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2006, he underwent a right total hip arthroplasty with stryker (howmedica) components, uncemented psl 54 od socket, 32mm crossfire polyethylene insert.Accolade hfx stem size 3 (ref no 6077-03358), and a 32mm +4 lfit anatomic v40 head (ref no 6077-0335) and a 32mm +4 lfit anatomic v40 head (ref no 6260-5-232).In (b)(6) of 2016, he had a sudden episode of weakness in the right leg, which concerned him and prompted evaluation of his right hip replacement.In the year preceding that episode, he had been experiencing a significant tremor of his hands, fatigue and reduced stamina.Metal suppression mri of right hip on (b)(6) 2016 showed a small pseudotumor just superior to the femoral neck with involvement of the gluteus medius tendon.Fdg pet brain scan and neuro q analysis showed abnormal hypometabolism in focal and generalized duster regions in a pattern compatible with chronic toxic encephalopathy.On (b)(6) 2016, serum / plasma cobalt level was 5.8 mcg/l and chromium was 1.7mcg/l.On (b)(6) 2016, right hip was revised to a zimmer wagner stem 190 by 14mm, trident x3 32id laterally offset liner, a 32mm delta ceramic +0 head, 3 luque 18 gauge wires, and 100 cc allopack graft.The superficial periprosthetic tissues were mildly inflamed.The trochanteric bursa was effused.The capsule was thickened and appeared viable.The posterior capsule was intact and the anterior capsule was partially at case end.The hip abductor tendons were about half detached from the great trochanter.There was proximal femoral bone deficiency of the stem that was treated with grafting and reduction osteoplasty.The final stability pattern posteriorly was 80 degrees before prosthetic anteriorly partially intact capsule restricted motion such that neither prosthetic or tissue impingement could be elicited.Cobalt level of fluid from the right hip joint was 1,100m mcg/l and chromium was 470 mg/dl.On (b)(6) 2016, he underwent a closed reduction of the right hip due to superior dislocation of the right revised right hip replacement.Fda safety report id# (b)(4).

• Brand Name: CROSSFIRE POLYETHYLENE INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYER, UNCEMENTED
• Manufacturer (Section D): STRYKER / HOWMEDICA OSTEONICS CORP.
• MDR Report Key: 9753988
• MDR Text Key: 181529640
• Report Number: MW5093292
• Device Sequence Number: 2
• Product Code: LWJ
• 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: 02/21/2020
• 4 Devices were Involved in the Event: 1 2 3 4

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2020
• 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: 77 YR
• Patient Weight: 99