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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

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

Event Date 12/29/2002

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, "hip arthroplasty after failed free vascularized fibular grafting for osteonecrosis in young patients" written by keith r.Berend, md, eunice gunneson, pa-c, james r.Urbaniak, md, and thomas p.Vail, md published by the journal of arthroplasty vol.18 no.4 2003 accepted by publisher 29 december 2002 was reviewed.The article's purpose to evaluate "the results and functional outcome of tha after failed fvfg in young patients with osteonecrosis of the femoral head." data was compiled from 73 patients (89 hips) who underwent tha surgeries between january 1985 and december 1995.Various implants were utilized including depuy and non-depuy products.The article does not identify which products are associated with specific adverse events, and the article does not provide adequate information to determine accurate quantities.The article implies that acetabular components wear matched to femoral components.Therefore it is assumed that if a depuy stem was implanted then depuy heads and acetabular components were utilized.Depuy products utilized: ultima stem, aml stem, srom stem, femoral head, cup ("shell"), liner.Adverse events: stem loosening (treated by revision), infection (treated by revision with liner exchange), osteolysis (treated by revision), loose cup (treated by revision), re-revision for loose stem (associated with aml stem), re-revision for "chronic instability" (associated with srom stem).

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 FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• 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: 9460304
• MDR Text Key: 185493808
• Report Number: 1818910-2019-122871
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2020
• 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