MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)

Event Date 09/01/2009

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

The literature article entitled, "durability of second-generation extensively porous-coated stems in patients aged 50 and younger" written by jennifer a.Moyer bs, catherine m.Metz md, john j.Callaghan md, david w.Hennessy bs, and steve s.Liu md published by clinical orthopedic related research published online 1 september 2009 was reviewed.The article's purpose was to report on whether second-generation extensively porous-coated cementless femoral stem in patients younger than 50 years of age would (1) be durable in terms of revisions; (2) provide high functional scores and reduce thigh pain; and (3) show radiographic durability of fixation and reduction in stress shielding.Data was compiled from 90 patients (89 hips) age 50 and younger from june 1994 to december 1999.The article reports that the prodigy femoral stem was mated with either non-depuy acetabular or depuy duraloc acetabular components.The article does not specify which acetabular components can be associated with the specific adverse events, and the article does not provide adequate information to determine accurate quantities.Article states no infections or loose components.Depuy products utilized: prodigy stem, duraloc cup (screws were used in all cases) and poly liner, metal head.Adverse events: mild thigh pain (no interventions, associated with femoral stem), dislocation (treated by revision and head and liner exchange), periprosthetic femoral fracture (treated by stem revision), liner wear (treated by revision with head and liner exchange), liner disassociation (treated by revision of head, liner, and cup exchange), osteolysis (radiographic findings, no interventions, commonly associated with liner wear), femoral stress shielding (radiographic findings, no interventions), acetabular radiolucency's (radiographic findings, no loosening's, no interventions).

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.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
• 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: 9416671
• MDR Text Key: 169257919
• Report Number: 1818910-2019-120734
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention