MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 LARGE MOD HEAD ADAPT 12/14 +5; HIP FEMORAL STEM/SLEEVE

Catalog Number 999800105

Device Problems Loss of or Failure to Bond (1068); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Osteolysis (2377); No Information (3190)

Event Date 11/17/2015

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(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.Wwcapa (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.

Event Description

New legal claim received from (b)(6).Xl system.Right hip.Revision has not taken place yet.(b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Depuy considers the investigation closed at this time.Should the 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

New legal claim received from (b)(6), xl system, right hip, revision has not taken place yet.(b)(4) update alert date 4th oct 2016.Attached scf, added revision date, added reasons for revision x 3 , added surgeons x 2 , added additional hospital, added full sleeve details and product code for stem, added manufacturing date for sleeve.Taken from scf dated (b)(6) 2016 and claimsuite dated (b)(6) 2016.Reason(s) for revision: component loosening : cup, osteolysis and metallosis update june 30, 2017 additional information received from kennedy, date of revision: (b)(6) 2016.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.

• Brand Name: LARGE MOD HEAD ADAPT 12/14 +5
• Type of Device: HIP FEMORAL STEM/SLEEVE
• 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: 5261584
• MDR Text Key: 32539951
• Report Number: 1818910-2015-36384
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999800105
• Device Lot Number: 2568042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2008
• 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): Other