MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problem Bone Fracture(s) (1870)

Event Date 08/31/2019

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.

Event Description

The literature article entitled, "subsidence and perioperative periprosthetic fractures using collarless hydroxyapatite-coated stem for displaced femoral neck fractures according to dorr type" written by joo-hyoun song, woo-lam jo, kee-haeng lee, yoon-joo cho, joonyoung park and seungbae oh published by journal of orthopaedic surgery accepted by publisher 31 august 2019.The article's purpose was to determine subsidence rate and incidence of perioperative periprosthetic fracture (ppf) of uncemented collarless corail stems for displaced femoral neck fractures according to dorr type.Data was compiled from 66 (dorr type a), 107 (dorr type b), and 49 (dorr type c) cases.Early subsidence is noted in 8 cases but all were well fixed within 2 years.Depuy product: corail stem.Adverse events: postoperative fractures (undetected intraoperatively and treated with non weight bearing progressing to partial weight bearing) intraoperative fractures (treated with wiring).

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.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10928358
• MDR Text Key: 218970946
• Report Number: 1818910-2020-25817
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention