MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

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

Patient Problems Fatigue (1849); Weakness (2145); Test Result (2695); No Code Available (3191)

Event Date 01/01/2017

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.

Event Description

It was reported that the patient also received a primary right hip tha on 2002 with the same depuy pinnacle metal-on-metal implant.In 2012, patient began experiencing symptoms of fatigue and difficulties with memory and muscle weakness in her legs.On 2017, patient blood cobalt level was 14.0 ppb and her urine cobalt evel was 109.9.The stem of the right hip was found by x-ray to be broken at the distal tip.On 2017, patient elected to have the right tha revised due to symptoms related to the broken stem and her rising cobalt levels.This hip was revised to cemented stryker exeter stem and ceramic on polyethylene articulation.Despite the revision, her cobalt level remained high.In 2018, her blood cobalt level was 9.4 ppb and her urine cobalt level was 35.6 ppb.She continue experiencing cognitive issue and mental fogginess and had progression of neuropathic weakness in both legs.An fdg pet brain scan showed focal and generalized hypometabolism consistent with chronic toxic encephalopathy.Doi: 2002; dor: 2017; right hip.

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.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9601804
• MDR Text Key: 186198016
• Report Number: 1818910-2020-02109
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

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 Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR