MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 DEPUY ASR XL FEM IMP SIZE 43; HIP FEMORAL HEAD

Catalog Number 999890143

Device Problem Metal Shedding Debris (1804)

Patient Problems Foreign Body Reaction (1868); Joint Swelling (2356); No Code Available (3191)

Event Date 01/29/2014

Event Type  Injury  

Event Description

Asr revision to take place (b)(6) 2014.Asr xl acetabular system - right, reason(s) for revision: raised cobalt levels.Effusion of hip joint.Correct lot no for stem - c51hw1000 patient name and claim no - mrs (b)(6).Update rec'd (b)(6) 2014 - revision date changed to (b)(6) 2014 - attached claimsuite.Update -manufacturing dates, received confirmation that revision has taken place.Taken from crawfords spreadsheet dated (b)(6) 2014.

Manufacturer Narrative

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Asr revision to take place (b)(6) 2014 asr xl acetabular system - right reason(s) for revision: raised cobalt levels.Effusion of hip joint correct lot no for stem - c51hw1000 patient name and claim no - (b)(6) - fnol-dep-jj-04520 update rec'd 29 jan 2014 - revision date changed to (b)(6) 2014 - attached claimsuite update -manufacturing dates, received confirmation that revision has taken place.Taken from (b)(6) spreadsheet dated (b)(6) 2014 update nov 17, 2017: email notification from (b)(6) received.There is no new information.This complaint was updated on nov 21, 2017.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.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: DEPUY ASR XL FEM IMP SIZE 43
• Type of Device: HIP FEMORAL HEAD
• 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: 3780891
• MDR Text Key: 18299469
• Report Number: 1818910-2014-17738
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,foreign,other
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 999890143
• Device Lot Number: 2716543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2008
• 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