MAUDE Adverse Event Report: DEPUY IRELAND 9616671 S-ROM*STM STD,30 NK,12X07X115; HIP FEMORAL STEM/SLEEVE

Catalog Number 523207

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 05/11/2016

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 stem was loose and had subsided.The srom femoral component and srom proximal sleeve was removed due to loosening/instability.

Manufacturer Narrative

The complaint states left hip revision performed on (b)(6) 2016 at (b)(6).Primary implant date (b)(6) 2014.Reason for revision; srom stem was loose and had subsided.The srom femoral component and srom proximal sleeve was removed due to loosening/instability.X-rays and photos are available.A (b)(6) female patient dob: (b)(6) 1952.No other information is available.A complaint database search did not identify any anomalies.A review of manufacturing records did not identify any anomalies.Without further information the root cause of the complaint cannot be determined.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).

• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, muenster ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, muenster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5666038
• MDR Text Key: 45477773
• Report Number: 1818910-2016-19545
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP070026
• 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: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 523207
• Device Lot Number: 4154466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2013
• 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
• Patient Age: 62 YR