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

Catalog Number UNK HIP FEMORAL AUGMENT

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

Patient Problems Ossification (1428); Unspecified Infection (1930); No Code Available (3191)

Event Date 03/11/2018

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

Literature article entitled, ¿wear kinetics of highly cross-linked and conventional polyethylene are similar at medium-term follow-up after primary total hip arthroplasty¿ by constantin mayer, md, et al, published by the journal of arthroplasty (2018), vol.33, pp.2671-2676, was reviewed.The aim of this present study was to assess the course and the long-term clinical and radiographic outcomes of thas with ceramic heads (28 and 32 mm) and hclpe inserts over a time course of 3.9-13.8 years.Implanted depuy products: duraloc acetabular cup and locking ring, acetabular screws, marathon polyethylene liner, ceramic femoral head, and s-rom stem and sleeve.All 72 thas in this study were done with depuy components.Results: 3 revisions of unknown products due to infection.25 cases of heterotopic ossification identified on progressive radiographic studies.9 cases of osteolysis identified on progressive radiographic studies.Progressive radiographic studies identified an unknown number of marathon liners with polyethylene wear and femoral head penetration.There were no patient consequences or adverse events associated with the polyethylene wear.Captured in this complaint: cup, head, stem, femoral sleeve, locking ring, and screws: surgical intervention, medical device removal, infection, extraskeletal ossification.(3) liner: surgical intervention, medical device removal, infection, extraskeletal ossification, and osteolysis.(3) liner: implant bearing wear, no patient consequences, no adverse events.

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.Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9587270
• MDR Text Key: 185620300
• Report Number: 1818910-2020-01779
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• 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 FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention