MAUDE Adverse Event Report: DEPUY INTL., LTD. - 8010379 DEPUY ASR XL FEM IMP SIZE 46; HIP FEMORAL HEAD

Catalog Number 999890146

Device Problems Malposition of Device (2616); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 11/07/2013

Event Type  Injury  

Event Description

Asr revision, asr xl acetabular system - left hip.Reason(s) for revision: component malalignment, pain, noise, alval/soft tissue damage.Surgeon form states that there was a large presence of black debris at the stem - 'considerable amount of debris at the interface blackish stem' update received (b)(6) 2014.Taper sleeve added.Hospital name amended.New boxes completed.

Event Description

Asr revision.Asr xl acetabular system - left hip.Reason(s) for revision: component malalignment, pain, noise, alval/soft tissue damage surgeon form states that there was a large presence of black debris at the stem - 'considerable amount of debris at the interface blackish stem' update received 11th february, 2014.Taper sleeve added.Hospital name amended.New boxes completed.Update - marked as legal, added additional hospital, updated surgery date.Taken from (b)(6) dated (b)(6) 2014.

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.

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 acetabular system - left hip.Reason(s) for revision: component malalignment, pain, noise, alval/soft tissue damage surgeon form states that there was a large presence of black debris at the stem - 'considerable amount of debris at the interface blackish stem.'.

Manufacturer Narrative

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.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 46
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTL., LTD. - 8010379; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTL., LTD. - 8010379; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3563194
• MDR Text Key: 4206549
• Report Number: 1818910-2014-10380
• 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: 02/20/2014

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: 999890146
• Device Lot Number: 2328644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 01/08/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/19/2014; 03/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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