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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Unspecified Infection (1930); Injury (2348); No Code Available (3191)

Event Date 12/06/2010

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, ""femoral component incarceration at the distal slot"" written by brian t.Palumbo, md, paul k.Edwards, md, naga udaya kiran thatimatla, md, and thomas l.Bernasek, md published by the journal of arthroplasty vol.26 no.8 2011 was reviewed.The article purpose was to reports on 2 cases with depuy products of 'incarceration' of femoral components.Each case is captured individually in linked complaints." this complaint captures case 2 of a (b)(6) year old woman with periprosthetic infection 5 years after srom revision tha.A 2 stage revision commenced and intraoperatively the stem was not able to be extracted successfully with multiple attempts.A c-arm fluoroscopy was utilized and revealed an osseous bar that formed through the coronal slot of the stem.An oscillating saw was used to perform a lateral femoral cortical window over the distal stem.The anterior tine and osseous bar were excised and then stem was then extracted.Osteotomy was repaired with cerclage cables and resection arthroplasty was completed.Seven months later she underwent a successful tha with non depuy femoral component.

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.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, 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: 9452147
• MDR Text Key: 176385310
• Report Number: 1818910-2019-122392
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR