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 Problem No Code Available (3191)

Event Date 02/01/2012

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, "the use of femoral struts and impacted cancellous bone allograft in patients with severe femoral bone loss who undergo revision total hip replacement" written by m.A.Buttaro, j.Costantini, f.Comba, and f.Piccaluga published by the journal of bone and joint surgery vol.94-b, no.2, february 2012 was reviewed for mdr reportability.The article identifies two cases with depuy products and adverse events that received femoral struts and impacted cancellous bone allograft in conjunction with depuy products.No other depuy products were identified.This complaint captures the first identified case of (b)(6) year old woman in figure 2a where it is noted that a depuy liner showed poly wear of a duraloc cementless well fixed acetabular cup, and the liner was exchanged intra-operatively.She also had a failed charnley stem.

Manufacturer Narrative

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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.

• 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: 9160356
• MDR Text Key: 168457928
• Report Number: 1818910-2019-107716
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/06/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention