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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)

Event Date 07/04/2011

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

"literature article entitled, ¿femoral revision surgery with impaction bone grafting¿ by b.L.E.F.Ten have, et al, published by the journal of bone and joint surgery (2012), vol.94-b, no.5, pp.615-618, was reviewed.The purpose of this prospective study was to evaluate the long-term clinical and radiological outcomes of revision of the femoral component of a total hip replacement using impaction bone grafting in 29 patients between september 1992 and september 1995.The article studies the outcomes of a competitor stem and head implanted during revision surgery.This complaint will capture the depuy components that were explanted during the revision surgery.Revised depuy products: 10 charnley stems and 3 minneapolis stems.The stems were paired with depuy femoral heads.Reasons for revision: aseptic loosening, pain, and periprosthetic fracture.The authors do not identify the reasons for revision by device manufacturer.The actual number of depuy stems associated with the following reasons for revision are unknown.There were no reported product problems with the femoral heads.Captured in this complaint: 13 stems: implant loosening of an unknown interface; fracture, pain, surgical intervention, medical device removal.13 femoral heads: no reported product problem; pain, surgical intervention, and medical device removal.".

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: root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9601441
• MDR Text Key: 188186266
• Report Number: 1818910-2020-02095
• Device Sequence Number: 1
• Product Code: KXA
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention