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

Catalog Number 999890145

Device Problem Noise, Audible (3273)

Patient Problems Irritation (1941); Pain (1994)

Event Date 03/03/2016

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 to take place on (b)(6) 2016, asr xl, right hip, reasons for revision: pain / noise / alval / soft tissue reaction.Update - alert date (b)(6) 2016.Received updated claimsuite & scf - see attachments dated (b)(6) 2016.(b)(6) confirmed revision has been rescheduled - revision due (b)(6) 2016, taken from claimsuite/scf dated (b)(6) 2016.Ek (b)(6) 2016.Update (b)(6) 2017 additional information received from (b)(6): date of revision is (b)(6) 2016.This com was updated on (b)(6) 2017.

Manufacturer Narrative

No device associated with this report was received for examination.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

Depuy considers the investigation closed at this time.Should the additional information be received, the informationwill 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

Additional narrative: revision of the device has been reported and there was no allegation that the device was a contributor to this event.No explanted devices have been received in respect of this patient for analysis.Manufacturing records could not be reviewed as no product lot numbers were provided.If further information is received indicating that the device was a contributor or there is an alleged deficiency of the device then this event will be re-opened for evaluation.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: 6710283
• MDR Text Key: 79926072
• Report Number: 1818910-2017-21070
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/19/2017

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: 999890145
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 06/23/2017; 10/09/2017; 11/11/2017
• Supplement Dates FDA Received: 07/17/2017; 10/17/2017; 11/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 67 YR