MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); No Code Available (3191)

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

An article entitled "mechanical failure of marathon cross-linked polyethylene acetabular liner after total hip arthroplasty".Literature article entitled, "mechanical failure of marathon cross-linked polyethylene acetabular liner after total hip arthroplasty" by matthew o.Barrett, md, et al published in american journal of orthopedics (2011) vol.40, no.10, pp.523-526 was reviewed for mdr reportability.This article documents a case of a retrieved marathon acetabular liner that had been fractured at the superior rim.A (b)(6) year-old female, weight (b)(6) lbs., bmi 19.6, underwent left primary tha due to severe hip dysplasia.She was implanted with a 46-mm pinnacle bantam acetabular cup with one dome screw, 28-mm marathon polyethylene liner, a femoral head, and s-rom femoral stem.Two years following primary tha, she presented with painful popping of the left hip and was referred for acetabular liner revision.Intraoperatively, the poly liner was found to be fractured at the anterosuperior margin.The head and the liner were exchanged while the cup and stem were well fixed and left in situ.Postoperative analysis of the liner revealed extensive wear on both sides of the liner indicating disassociation from the cup and fracture of the liner due to shearing of the locking mechanism tabs.At follow-up, the patient reported no further complications.

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).No device associated with this report was received for examination.Visual examination of the provided x-ray images and photographs 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. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8961588
• MDR Text Key: 161263026
• Report Number: 1818910-2019-103079
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention