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

Catalog Number 999804451

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Pain (1994); Disability (2371)

Event Date 08/30/2012

Event Type  Injury  

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ asr revision, type of product: unknown, side hip to be revised: left.Reason(s) for revision: night pain, restricted range of motion, function impaired and the hip was dry and the surrounding tissue macroscopically normal.Update received: (b)(6) 2013 - added patient reference number: (b)(4), patient name: (b)(6), added product type: asr resurfacing system and reason for revision: pain.Update (b)(6) alert received.Added head product and corrected hospital.

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.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

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy still considers this case closed to capa.

Event Description

Update - two files were duplicated with crawfords - have now changed the 47 reference number from (b)(4).(b)(4) is an invalid ref number.See email dated 1st dec 2015.Filled out all mw fields, manufacturing and expiry dates.Added additional reason for revision taken from scf dated 24th nov 2015.Reason(s) for revision: component loosening.

Manufacturer Narrative

Additional information received indicating that the device is not contributing to the issue; therefore; this report is being rejected.

• Brand Name: TOTAL ASR 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: 3954205
• MDR Text Key: 4560103
• Report Number: 1818910-2014-24120
• 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: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2012
• Device Catalogue Number: 999804451
• Device Lot Number: 2346275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2007
• 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
• Patient Age: 68 YR