MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE HFX SIZE #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6077-0335

Device Problem Corroded (1131)

Patient Problems Weakness (2145); Injury (2348); Reaction (2414)

Event Date 08/18/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Other text : device not returned.

Event Description

It was reported through a medwatch 5093292: "patient id:[.]; on [.] 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 #6077-03358), and a 32mm +4 lfit anatomic v40 head (ref #6077-0335) and a 32mm +4 lfit anatomic v40 head (ref #6260-5-232).In [.] 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 [.] 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 [.] 2016, serum/ plasma cobalt level was 5.8 mcg/l and chromium was 1.7mcg/l.On [.] 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 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 [.] 2016, he underwent a closed reduction of the right hip due to superior dislocation of the right revised right hip replacement.".

• Brand Name: ACCOLADE HFX SIZE #3
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 9944068
• MDR Text Key: 187102091
• Report Number: 0002249697-2020-00721
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327021196
• UDI-Public: 07613327021196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2020

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
• Device Operator: Health Professional
• Device Model Number: 6077-0335
• Device Catalogue Number: 6077-0335
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention