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 Death (1802); Heart Failure (2206)

Event Date 09/03/2008

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Report source is a literature article.There is limited information regarding the reported death.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, "penetration of a metallic femoral head through the acetabular shell" written by robert a.Sherman, md, and timothy a.Damron, md published by the journal of arthroplasty vol.24 no.7 2009 accepted by publisher 3 september 2008 was reviewed.The article purpose was to report on one case of a (b)(6) man who underwent l tha implanted with depuy profile stem and acetabular cup system.Medical history includes coronary artery disease, hypertension, osteoarthritis, dysrhythmia and trigeminal neuralgias.Eighteen years post implantation he presented painful hip rom and a shortened, externally rotated left lower extremity.Radiographs revealed the appearance of a traditional dislocation but the head/neck was noted to be overlying the acetabular component on both anteroposterior and lateral views so no attempts at closed reduction.Revision operation was performed and intraoperative findings included metallosis, eroded poly liner and eroded metal shell, osteolysis with supra-acetabular bone surrounded by blackened metal debris.All components including stem were removed and replaced.Cancellous allograft utilized in acetabulum and allograft struts utilized in femur in conjunction with cable plate and wiring.It was estimated a 1300 ml blood loss.Patient was placed in icu and within 12 hours his medical condition worsened necessitating re-intubation and immediately followed by catastrophic cardiac injury and died.Depuy products utilized: profile stem, metal head, metal cup, poly liner.Adverse events: death, cardiac failure, dislocation, revision, foreign body reaction (stemming from liner, cup and head as the liner was worn and cup and head resulted in metal debris with note of implant errosion), major bleed, pain.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Corrected: h6.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 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 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: 9427055
• MDR Text Key: 169561466
• Report Number: 1818910-2019-121580
• Device Sequence Number: 1
• Product Code: KWA
• 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
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death