UNCEMENTED PSL 54 OD SOCKET

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for UNCEMENTED PSL 54 OD SOCKET manufactured by Stryker / Howmedica Osteonics Corp..

Event Text Entries

[181529640] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093292
• MDR Report Key: 9753988
• Date Received: 2020-02-25
• Date of Report: 2020-02-21
• Date of Event: 2016-06-08
• Date Added to Maude: 2020-02-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: UNCEMENTED PSL 54 OD SOCKET
• Generic Name: PROSTHESIS, HIP, SMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Product Code: LWJ
• Date Received: 2020-02-25
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER / HOWMEDICA OSTEONICS CORP.

Device Sequence Number: 2

• Brand Name: CROSSFIRE POLYETHYLENE INSERT
• Generic Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYER, UNCEMENTED
• Product Code: LWJ
• Date Received: 2020-02-25
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: STRYKER / HOWMEDICA OSTEONICS CORP.

Device Sequence Number: 3

• Brand Name: ACCOLADE HFX STEM SIZE 3
• Generic Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYER, UNCEMENTED
• Product Code: LWJ
• Date Received: 2020-02-25
• Catalog Number: 6077-0335
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: STRYKER / HOWMEDICA OSTEONICS CORP.

Device Sequence Number: 4

• Brand Name: STRYKER COCR LFIT ANATOMIC V40 HEAD AND COCR ACCOLADATE HFX STEM
• Generic Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYER, UNCEMENTED
• Product Code: LWJ
• Date Received: 2020-02-25
• Catalog Number: 6260-5-232
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: STRYKER / HOWMEDICA OSTEONICS CORP.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2020-02-25