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

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problem Death (1802)

Event Date 03/27/2013

Event Type  Death  

Manufacturer Narrative

(b)(4).Report source for death is a literature article.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The literature article entitled, "no difference in mortality between cemented and uncemented hemi prosthesis for elderly patients with cervical hip fracture.A prospective randomized study on 334 patients over 75 years." written by o.Talsnes, f.Hjelmstedt, a.H.Pripp, o.Reikeras, and o.E.Dahl published by archives of orthopaedic and trauma surgery published online 27 march 2013 was reviewed.The article's purpose was to review cases to determine if there are no differences in bleeding parameters, surgery time and mortality by the use of uncemented versus cemented hemi prosthesis in the treatment of dislocated femoral neck fractures for elderly.Data was compiled from 334 patients (172 in cement group and 162 in cemented group).Both groups received a depuy bipolar implant (depuy titan cemented or depuy corail uncemented).Manufacturer of cement not identified.The article reports one patient died in each group on day of surgery.The article also reports patients received blood transfusions intraoperatively and postoperatively in both groups.Depuy products: titan bipolar construct (stem, head, head), corail bipolar construct (stem, head, head).Adverse events: death in each group.Blood loss in each group.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.

Manufacturer Narrative

Product complaint # (b)(4).H10 additional narrative: added: g3 report source: literature.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10580377
• MDR Text Key: 208351887
• Report Number: 1818910-2020-20805
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death