MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Corroded (1131); Degraded (1153); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Nerve Damage (1979); Tissue Damage (2104); Not Applicable (3189); No Code Available (3191)

Event Date 08/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled, "growth of an intrapelvic pseudotumor associated with a metal-on-metal total hip arthroplasty after revision arthroplasty causing a femoral nerve neuropathy" written by patrick leung, md and james c.Kudrna, md, phd published by arthroplasty today 2 (2016) 105-109 available online 21 august 2016 was reviewed.The article's purpose was to report on one case study of a (b)(6) year old male who received a left tha with cementless summit stem, cementless pinnacle cup, ultamet mom bearing.Six years post op he presented with thigh numbness, paresthesia and left leg weakness.Co and cr levels were elevated at 76.4 and 75.6 ppb respectively.Mri revealed 2 heterogenous lesions - one within iliacus extending into iliopsoas and one proximal femur.Electromyography revealed decreased recruitment in vastus medialis and iliopsoas.Revision arthroplasty was performed with debridement and head and liner exchange.Intraoperatively, several pseudotumor were debrided.Also minimal corrosion and fretting and the head-stem junction was noted.Noted with metallic staining of tissue.Ten months post revision the patient continued to experience progressive numbness and paresthesia in medial thigh leading to instability of the knee with ambulation and difficulty ascending/descending stairs which then required an assistive device for functional mobility.Another mri revealed a persistent pseudotumor within iliopsoas and proximal femur but larger than original pseudotumor.The patient underwent a laparoscopic removal of the retroperitoneal pseudotumor.Four months post excision, symptoms remained unchanged and clinical exam revealed mild quadriceps atrophy with decrease sensation to l3-l4 dermatomes; nerve condition studies revealed absent saphenous nerve conduction and electromyography demonstrated abnormal vastus lateralis and rectus femoris response.Repeat mri revealed interval resolution of the pseudotumor.Twelve months post excision, quadriceps strength improved and partial return of sensation over the anteromedial thigh.Seventeen months post excision, motor deficits resolved and assistive devices were discontinued.Parasthesias in the anteromedial thigh persisted at 35 months post excision but patient had resumed and returned to normal function and recreational activities without negative impact.Depuy products utilized: summit stem, pinnacle cup, mom bearings.Adverse event: nerve injury, pseudotumors, elevated blood metal ions, lesions in soft tissue, revision entailing head and liner exchange, corrosion noted on head/stem junction, muscle weakness/atrophy, difficulty in walking, surgical intervention to excise pseudotumor.

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) used to capture blood heavy metal increased.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Visual examination of the provided images confirmed the reported event.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9411577
• MDR Text Key: 185333799
• Report Number: 1818910-2019-120230
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention