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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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, "hydroxyapatite coated hip hemiarthroplasty: morbidity and mortality" written by muhammad ali fazal, sunil sha, and padmanabhan subramanian published by journal of clinical orthopaedics and trauma made available online on 8 may 2020 was reviewed.The article's purpose is the study the morbidity and mortality of treating displaced intra capsular hip fractures in elderly with a fully hydroxyapatite coated collared femoral stem with a modular monopolar head.It is noted that all patients received corail stem with cocr femoral head.The article reports no perioperative mortalities.Figure 1 provides radiographic image of post operative implantation and no note of adverse event in caption description.Depuy product: corail stem, cocr femoral head.Adverse events: intraoperative fracture (treated by cable wire), infection (treated by washout and iv antibiotics), dislocation (treated by closed reduction and or conversion to tha), post op periprosthetic fracture (treated by revision to longer stem).

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 HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10879512
• MDR Text Key: 217641703
• Report Number: 1818910-2020-25176
• 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
• Report Date: 11/16/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention