MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ADAPTER SLEEVES 12/14 +2; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999800312

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Pain (1994); Test Result (2695)

Event Date 01/01/2012

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.

Event Description

Litigation alleges that the patient is required to live with pain, crunching, limping, popping, elevated levels of metal ions in his blood and continues to require ongoing medical care for both hips.Doi: (b)(6) 2007 right hip dor: none reported, doi: (b)(6) 2008 left hip dor: none reported, patient is bilateral, patient is a resident of (b)(6).Update - (b)(6) 2013 - plaintiff's preliminary disclosure form was received, which identified part/lot information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.This pc is for the left hip.(b)(4) for the right hip.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ADAPTER SLEEVES 12/14 +2
• Type of Device: ASR HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; : st. anthony's rd; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; : st. anthony's rd; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7374027
• MDR Text Key: 103584079
• Report Number: 1818910-2018-56211
• 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: consumer,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2012
• Device Catalogue Number: 999800312
• Device Lot Number: 2519992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 09/07/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 12/15/2007
• 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: 65 YR