MAUDE Adverse Event Report: DEPUY IRELAND 9616671 S-ROM*SLEEVE PRX ZT HA 20D-LRG; HIP FEMORAL STEM/SLEEVE

Catalog Number 550113

Device Problem Loss of Osseointegration (2408)

Patient Problem No Information (3190)

Event Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Reason for revision: srom femoral prosthesis loosening - sleeve and stem.

Manufacturer Narrative

The complaint states second revision right total hip arthroplasty.Primary operation date: unknown.First revision date: (b)(6) 2014 mater hospital sydney.Second revision date: (b)(6) 2017.Reason for revision: srom femoral prosthesis loosening - sleeve and stem.Removal of srom stem, sleeve and ceramic head.Removal of ceramic liner.X-ray photos, explanted implant photos and photos of first revision component implant stickers available.A complaint database search did not identify any anomalies.A review of manufacturing records did not identify any anomalies.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, muenster ; EI
• Manufacturer (Section G): DEPUY IRELAND 9611671; loughbeg, ringaskiddy co.; cork, muenster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6342281
• MDR Text Key: 67800803
• Report Number: 1818910-2017-12886
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 550113
• Device Lot Number: 3348045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2011
• 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