MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SROM*STM ST,36+8L NK,24X19X175; HIP FEMORAL STEM/SLEEVE

Catalog Number 523424

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Pain (1994)

Event Date 06/12/2014

Event Type  Death  

Manufacturer Narrative

This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Ref.Wwcapa (b)(4); there is an ongoing investigation regarding the root cause(s) and/or corrective actions.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation documents received; patient underwent a revision to address pain and elevated metal ions.Per litigation: "on (b)(6) 2014, (b)(6) died as a direct result of complications from explanting the recalled depuy asr hip implant.".

Manufacturer Narrative

(b)(4).The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Event Description

Update 7/7/16 medical records received.After review of the medical records for mdr reportability, stickers provided part/lot numbers the complaint was updated on:07/25/2016.

• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster IN ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster IN ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5759809
• MDR Text Key: 48480437
• Report Number: 1818910-2016-22413
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2010
• Device Catalogue Number: 523424
• Device Lot Number: 1976701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2005
• 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): Death; Required Intervention
• Patient Age: 60 YR