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 Wound Dehiscence (1154); Thrombosis (2100); Joint Dislocation (2374); No Code Available (3191)

Event Date 01/17/2018

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, "john charnley award: randomized clinical trial of direct anterior (daa) and miniposterior approach (mpa) tha: which provides better functional recovery?" written by michael j.Taunton, md, robert t.Trousdale, md, rafael j.Sierra, md, ken kaufman, phd, and mark w.Pagnano, md published by clinical orthopaedics and related research published online 17 january 2018.The article's purpose was to study and find answers to if daa result in faster return to activities of daily living than the mpa; if daa have superior patient-reported outcome measures than the mpa; if the daa result in improved radiographic outcomes than the mpa; and if daa have a higher risk of complications than the mpa.Data was compiled from 101 patients undergoing primary tha between march 1, 2013 and may 31, 2016.All components were uncemented and were depuy for the mpa group.The article does not identify the components for the daa group; therefore, only adverse events associated with mpa group are captured in this complaint.Depuy products utilized: corail stem, pinnacle cup, ceramic head and poly liner.Adverse events: 1) dislocation (treated with closed reductions) 2) wound dehiscence (treated with dressing changes and oral antibiotics) 3) intraoperative calcar fractures (treated with cables) 4) deep vein thrombosis (treated with xarelto).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch 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: 9981677
• MDR Text Key: 188390352
• Report Number: 1818910-2020-11069
• Device Sequence Number: 1
• Product Code: KWA
• 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: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention