MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 LARGE MOD HEAD ADAPT 12/14 +5; HIP FEMORAL STEM/SLEEVE

Catalog Number 999800105

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Pain (1994)

Event Date 01/23/2014

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.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.Ref.(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

New etq record created in order to update etq (legacy system) (b)(4).Reason for original complaint: asr revision, asr xl - left.Reason(s) for revision: pain, osteolysis, increased cobalt and chromium levels and left femur neck fracture.Update received 24th january, 2014.Stem product code added.Crawfords reference number added.Update received: 23rd february 2014 - added hospital name: (b)(6), added surgeon name: (b)(6) and amended revision date: (b)(6) 2013.(b)(4).Update 13 nov 2015: rec'd legal letter from (b)(6) with following information: patient name, sex and dob.Correct revision date.Also added man/exp dates for all products and filled in any missing mw fields.(b)(6) 2015.

• Brand Name: LARGE MOD HEAD ADAPT 12/14 +5
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5274999
• MDR Text Key: 32963034
• Report Number: 1818910-2015-36679
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/13/2015

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: 06/02/2013
• Device Catalogue Number: 999800105
• Device Lot Number: 2649390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR