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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 04/28/2014

Event Type  malfunction  

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, "a new technique of subtrochanteric shortening in total hip arthroplasty" written by simon pearce, amir-reza jenabzadeh, william l walter, and ronald mark gillies published by bmj case rep.2014 may 20;2014.Pii: bcr2013202813.Doi: 10.1136/bcr-2013-202813 accepted by publisher 28 april 2014 was reviewed.The article's purpose was to present two cases of patients with srom modular hip system that experienced fracture of the femoral prosthesis.Each case is captured individually in linked complaints.This complaint captures case 1 of a (b)(6) year old woman who had a onset of right sided thigh pain when bearing weight without any episodes of trauma 4 years post implantation.It was discovered that a prosthesis fracture occurred on the posterior tine of the slotted section of the stem.She was managed conservatively with analgesics and protective weight bearing with pain resolving and disappearing within 8 weeks of onset.No revision surgery.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.H10 additional narrative: product complaint #
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> (b)(4).Investigation summary
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> 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.Device history lot
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> null device history batch
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> null device history review
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> null if information is obtained that was not available for the initial medwatch, a follow-up 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
• MDR Report Key: 9313508
• MDR Text Key: 219773353
• Report Number: 1818910-2019-112706
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1