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

Catalog Number 999890145

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Joint Swelling (2356); No Code Available (3191)

Event Date 08/28/2012

Event Type  Injury  

Event Description

Asr revision; asr xl; left; reason(s) for revision : pain / effusion / raised metal ions.Cup original implant date (b)(6) 2007; remaining products original implant date (b)(6) 2007; 2nd revision of 2 - (b)(4).Bilateral patient - right side not revised.

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.(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

Asr revision, asr xl, left, reason(s) for revision: pain / effusion / raised metal ions, cup original implant date (b)(6) 2007, remaining products original implant date (b)(6) 2007, 2nd revision of 2 - see (b)(4) for 1st revision, bilateral patient - right side not revised.Update: updated original implant date, name of hospital, file handler details, expiry dates for all products and lot numbers, manufacture date and manufacturing location for head, stem and sleeve.Taken from email 11 march 2015 (pd 15 march 2015).(b)(6) reference number added from (b)(6) spreadsheet attached and complaint type changed to legal.(b)(6) details changed to (b)(6).(pd 15 march 2015) 21 march 2015 - rcvd update - corrected implant date to correct abv (b)(6) 2007 - kf 25/03/2015.

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

Asr revision, asr xl, left, reason(s) for revision : pain / effusion / raised metal ions.Cup original implant date (b)(6) 2007.Remaining products original implant date (b)(6) 2007.2nd revision of 2 - (b)(4)for 1st revision.Bilateral patient - right side not revised.Update: updated original implant date, name of hospital, file handler details, expiry dates for all products and lot numbers, manufacture date and manufacturing location for head, stem and sleeve.Taken from email 11 march 2015 (pd 15 march 2015) kid reference number added from (b)(6) spreadsheet attached and complaint type changed to legal.(b)(6) details changed to (b)(6).(pd 15 march 2015).

• Brand Name: DEPUY ASR XL FEM IMP SIZE 45
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD.; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD.; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 3936742
• MDR Text Key: 4573953
• Report Number: 1818910-2014-23469
• 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
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2015

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: 07/28/2012
• Device Catalogue Number: 999890145
• Device Lot Number: 2434789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2015
• Initial Date FDA Received: 07/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/24/2015; 04/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2007
• 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: 64 YR