MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 DEPUY ASR XL FEM IMP SIZE 51; HIP FEMORAL HEAD

Catalog Number 99989015

Device Problem Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 01/03/2017

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# 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.

Event Description

Asr revision due (b)(6) 2017, asr xl, right, reason for revision: pain / noise / alval/soft tissue reaction.Update: alert date 24 jan 2017.Added product code and amended lot number, added manufacture date and facility for cup.Added product code and lot number, added manufacture date and facility for stem.Update 15jun2017: additional information received from (b)(4), as per review of the new information there is no update to the com.

Event Description

Additional information received from kennedy.Received part and lot information.Updated the head part and lot information as well as the date of implant.There is no new information added that changes the mdr decision.This complaint was updated on: (b)(6) 2017.

Manufacturer Narrative

Asr revision due (b)(6)2017.Asr xl.Right.Reason for revision : pain / noise / alval/soft tissue reaction.Alert date: (b)(6)2017.Update 15jun2017: additional information received from (b)(4) as per review of the new information there is no update to the com.Update jul 21, 2017: additional information received from (b)(4).Received part and lot information.Upated the head part and lot information as well as the date of implant.This complaint was updated on: 08 aug 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.

Manufacturer Narrative

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 51
• 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: 6708412
• MDR Text Key: 79854257
• Report Number: 1818910-2017-21016
• 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: distributor,health profession
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2017

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 Catalogue Number: 99989015
• Device Lot Number: 2380008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 07/12/2017
• Supplement Dates Manufacturer Received: 07/21/2017; 08/25/2017; 08/25/2017
• Supplement Dates FDA Received: 08/09/2017; 09/05/2017; 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2008
• 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