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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Osteolysis (2377); No Code Available (3191)

Event Date 01/01/2007

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, "separation of the apex hole eliminator screw in four failed hybrid total hip arthroplasties" written by f.Comba, m.A.Buttaro, and f.Piccaluga published by hip international / vol.17 no.1, 2007 / pp.40-44 was reviewed for mdr reportability.The article reports upon 4 individual cases in which a separation of the apex hole eliminator screw was associated to acetabular osteolysis and aseptic failure of a charnley stem after a hybrid tha.No further explanation on the apex hole eliminator separation.The article identifies the acetabular components as depuy duraloc uncemented cups and depuy enduron poly liner.The cups' central holes were sealed with apex hole eliminator screws.The article reports all four cases received bone allograft to fill the acetabular lesions and a new apex hole eliminator was used and liner was changed during revision.The article identifies depuy charnley stems were utilized with 3rd generation cementing techniques but does not clarify if depuy cement was utilized.The article reports stem loosening was confirmed intraoperatively in all four cases and each case received bone impaction allografting technique to reconstruct bone loss and replaced a depuy c-stem component.Each case is captured individually in linked complaints.This complaint captures case 2 of a (b)(6) year old male with initial implantation in 1999 and received revision in 2004.

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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: null.Device history batch: null.Device history review: null.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: 9160351
• MDR Text Key: 168458753
• Report Number: 1818910-2019-107711
• 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,literature
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2019
• 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: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR