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

Catalog Number 999800105

Device Problems Nonstandard Device (1420); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/07/2015

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 (b)(6) 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.(b)(4).

Event Description

Asr revision not taken place.Asr xl - left hip.Reason for revision: unknown.Bilateral: see (b)(4) for right hip.

Event Description

Update nov 3, 2017: email notification received.Dor provided.This complaint was updated on nov 7, 2017.

Manufacturer Narrative

Asr revision not taken place asr xl - left hip reason for revision: unknown bilateral: see com 062063 for right hip update nov 3, 2017: email notification received.Dor provided.This complaint was updated on nov 7, 2017.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: 5008398
• MDR Text Key: 23188639
• Report Number: 1818910-2015-28308
• 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: foreign,other
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Followup,Followup
• Report Date: 08/07/2015

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 Expiration Date: 04/12/2011
• Device Catalogue Number: 999800105
• Device Lot Number: 2109271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Supplement Dates Manufacturer Received: 11/03/2017; 11/09/2017
• Supplement Dates FDA Received: 11/08/2017; 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2006
• 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