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

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problems Loss of Osseointegration (2408); Unintended Movement (3026); Migration (4003)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 04/06/2005

Event Type  Injury  

Manufacturer Narrative

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.

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, ¿results on total hip arthroplasties with femoral shortening for crowe¿s group iv dislocated hips¿ by hiroyuki makita, md, phd, et al, published by the journal of arthroplasty (2007), vil.22, no.1, pp.32-38, was reviewed.The purpose of this article is to review the postoperative results of total hip arthroplasties in 12 female patients with crowe¿s group iv with completely dislocated hips, implanted between 1990 and 2002.Both depuy and competitor products were used in this study.Implanted depuy products: 5 s-rom cups.2 duraloc cups with locking rings, 7 unknown acetabular liners, and 8 s-rom stems with sleeves paired with 22-mm femoral heads.Results: there is insufficient information to determine the manufacturers of the component associated with the following adverse events.The total number of impacted depuy products is unknown.1 stem revised at 8 years due to implant migration secondary to aseptic loosening.2 postoperative superficial infections.There were no surgical interventions or revisions associated with the superficial infections.There is insufficient information provided to determine the severity of the infections.2 peripheral nerve injuries- no treatment required.1dislocation 3 weeks postoperatively treated with closed reduction.Captured in this complaint: liner and head: implant dislocation.Stem and augment: implant migration and implant loosening at the bone to implant interface.Health impact codes: surgical intervention, medical device removal.Symptoms codes: nerve injury, infection, joint dislocation.There were no reported product problems with the acetabular cups and locking rings.

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9622462
• MDR Text Key: 184959053
• Report Number: 1818910-2020-02670
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention