MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 DEPUY ASR XL FEM IMP SIZE 45; HIP FEMORAL HEAD

Catalog Number 999890145

Device Problem Insufficient Information (3190)

Patient Problem Host-Tissue Reaction (1297)

Event Date 10/31/2014

Event Type  Injury  

Event Description

Asr revision to take place on (b)(6) 2014.Asr xl.Left.Reason(s) for revision: alval / soft tissue reaction.(b)(6)-2014 query original surgery date.Update - received confirmation that revision has taken place.Taken from (b)(6) spreadsheet dated (b)(6) 2014.

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.(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.(b)(4).

Manufacturer Narrative

Depuy considers the investigation closed at this time.Should the 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.

Manufacturer Narrative

Asr revision to take place on 08 nov 2014: asr xl, left.Reason(s) for revision: alval / soft tissue reaction.On 03-nov-2014 query original surgery date.Update - received confirmation that revision has taken place.Taken from (b)(6) spreadsheet dated (b)(6) 2014.Update - added stem details taken from claimsuite dated (b)(6) 2015.Update- june 14, 2017 additional information received from (b)(6): correct surgery date: (b)(6) 2008.Correct date of revision: (b)(6) 2014.This complaint was updated on june 22, 2017.Update 6/14/2017 (b)(6) update records reviewed for mdr reportability.Agreement with current mdr decisions.No further changes indicated.Complaint updated on: 7/12/2017.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 45
• 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: 4330749
• MDR Text Key: 5242487
• Report Number: 1818910-2014-34272
• Device Sequence Number: 1
• Product Code: JDG
• 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: 12/05/2014

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 Expiration Date: 08/15/2012
• Device Catalogue Number: 999890145
• Device Lot Number: 2445740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/15/2014
• Supplement Dates Manufacturer Received: Not provided; 06/27/2017
• Supplement Dates FDA Received: 06/22/2017; 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2007
• 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