MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 49; HIP FEMORAL HEAD

Catalog Number 999890149

Device Problem Malposition of Device (2616)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Tissue Damage (2104)

Event Date 04/12/2013

Event Type  Injury  

Event Description

Asr revision.Asr xl.Left.Reason(s) for revision: component loosening - cup.Non depuy competitor stem.This com is to be closed to capa due to the reasons for revision falling within the capa remit and off label use of a competitor stem.Update received 7th may 2014.Surgeon name amended.Construct type and common name amended for taper sleeve.Surgeon confirmation form also received (b)(4) 2014.Querying reasons for revision as component loosening is not on the scf.Additional reasons for revision and additional hospital added.Reason(s) for revision: component loosening - cup incorrect, component malalignment, pain, alval / soft tissue reaction.Query response on (b)(4) 2014 confirms that component loosening is not a reason for revision.Reason(s) for revision: component malalignment, pain, alval / soft tissue reaction.

Manufacturer Narrative

Additional 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.(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.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: 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.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-(b)(4).Ongoing post market surveillance is conducted per our procedures for this product.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 49
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 3822310
• MDR Text Key: 16015144
• Report Number: 1818910-2014-19172
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,consumer,foreign,other
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2014

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: Physician
• Device Catalogue Number: 999890149
• Device Lot Number: 1852454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2014
• Initial Date FDA Received: 05/20/2014
• Supplement Dates Manufacturer Received: 09/28/2018; 10/16/2018
• Supplement Dates FDA Received: 10/11/2018; 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention