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 Pain (1994); No Code Available (3191)

Event Date 08/07/2010

Event Type  Injury  

Event Description

New etq record created in order to update etq (legacy system) complaint (b)(4).Reason for original complaint ¿ asr revision right asr hip resurfacing system.Reason for revision: component loosening (cup), pain, component malalignment -incorrect see below update received: (b)(4) 2014 - added hospital: (b)(6), amended product type: asr xl and added products: stem and taper sleeve.Update received (b)(4) 2014.Full information and corrected scf received (b)(4) 2014.Lot numbers amended for cup and femoral head.Manufacturing dates amended.Malposition is not a reason for revision.Reason for revision: component loosening (cup), pain.Bilateral patient - see (b)(4) for left hip.

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ asr revision.Right asr hip resurfacing system.Reason for revision: component loosening (cup), pain, component malalignment.Update: attached another scf, no changes made to dint - received (b)(4) 2012.Update received: (b)(4) 2014 - added hospital: (b)(6), amended product type: asr xl and added products: stem and taper sleeve.

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 u.S.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.Ref.(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

Depuy still considers the investigation closed.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy still considers the investigation closed.Should additional information be received the investigation will be reopened.

Event Description

Confirmation of a deceased patient.There is no indication that the device contributed to death.Added additional reason for revision.Additional reason for revision : elevated ion levels.Date of death (b)(6) 2016.

• 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 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: 3747345
• MDR Text Key: 4377094
• Report Number: 1818910-2014-16659
• 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: Other,Foreign,foreign,other
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2014

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: 1832028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2014
• Initial Date FDA Received: 04/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/24/2014; 02/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2004
• 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
• Patient Age: 64 YR