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 10/12/2009

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.No device was received.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.(b)(4).

Event Description

Literature article entitled, ¿individual susceptibility to periprosthetic osteolysis is associated with altered patterns of innate immune gene expression in response to pro-inflammatory stimuli¿ by andrew gordon, et al, published by journal of orthopaedic research (2010), pp.1127-1135, doi 10.1002/jor.21135, was reviewed.The purpose of this study was to examine whether individuals with a susceptibility to osteolysis after tha have quantitatively different innate immune responses to pro-inflammatory stimuli versus individuals who do not display this susceptibility.All patients in the study group were revised for osteolysis and implant loosening between march and november 2005.Implanted depuy products: charnley tha cemented with competitor cement- polyethylene head, 22-mm femoral head, and femoral stem.Results: there were no revisions or complications of the revised prostheses.This complaint captures the charnley tha index prostheses revised due to aseptic loosening secondary to osteolysis.28 charnley cups- examination of the explanted cups identified polyethylene wear.29 charnley stems captured in this complaint: charnley cup: implant loosening of an unknown interface, implant bearing wear.Femoral head: no reported product problem.Charnley stem: implant loosening of an unknown interface.Patient harms: osteolysis, surgical intervention, medical device removal.

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9417829
• MDR Text Key: 185198890
• Report Number: 1818910-2019-120912
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention