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

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Thrombosis (2100); Tissue Damage (2104); No Code Available (3191)

Event Date 08/29/2018

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.

Event Description

The literature article entitled, "do postoperative results differ in a randomized trial between a direct anterior and a direct lateral approach in tha" written by knut erik mjaaland md, kjetil kivle md, svein svenningsen md, phd, and lars nordsletten md, phd published by clinical orthopaedics and related research made available online on 29 august 2018 was reviewed.The article's purpose was to compare the direct anterior approach with the direct lateral approach to tha with respect to various outcomes.Data was compiled from 164 patients with follow ups at 3, 6, 12 and 24 months including harris hop score, 6 minute walk distance test, trendelenburg test and oxford hip score.All patients received depuy products with exception of the unidentified cement manufacturer.Depuy products: cemented all poly marathon cup, uncemented corail stem, ceramic head, ceramic head.Adverse events reported: nerve injury (some self resolved, some treated and one permanent but no motor function loss).Avulsion of the greater trochanter (treated with cable wire during primary with no sequelae).Infection (treated by antibiotics, revision).Detachment of released part of gluteus medius (treated by surgical intervention).Dvt (treated by warfarin).Pulmonary embolus (treated by warfarin).

Manufacturer Narrative

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.

• 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: 10844609
• MDR Text Key: 216409190
• Report Number: 1818910-2020-24696
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention