MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 53; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890153

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Death (1802); No Code Available (3191)

Event Date 07/27/2010

Event Type  Death  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.No procode, pma/510k.Initial reporter occupation: non-healthcare professional: "attorney".(b)(4).

Event Description

Asr claim letter record received.It was reported that the original claimant has died and their estate is claiming the death was a caused by the revision surgery and/or medical condition consequent on the revision surgery.The cause of death has been asserted as pulmonary embolism (pe).Doi: (b)(6) 2009; dor: (b)(6) 2010; unknown hip.

Manufacturer Narrative

(b)(4).Revision of the device had taken place and the allegations indicates the patient sustained a pe (pulmonary embolism) and death after the revision.At this time our devices cannot be excluded as a possible cause of the pe and death.No explanted devices have been received in respect of this patient for analysis.Manufacturing records have been reviewed and the device(s) met specification prior to placing on the market.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 53
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8310362
• MDR Text Key: 135166638
• Report Number: 1818910-2019-83368
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999890153
• Device Lot Number: 2611855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2008
• 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): Death; Required Intervention