MAUDE Adverse Event Report: DEPUY INTL., LTD. - 8010379 DEPUY ASR XL FEM IMP SIZE 43; HIP FEMORAL HEAD

Catalog Number 999890143

Device Problems Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)

Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 03/02/2014

Event Type  Injury  

Event Description

Asr xl - left.Reason(s) for revision: pain, possible component loosening (cup), possible metallosis.Update received (b)(6) 2014.Lot number added for cup and head.Manufacturing dates added.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.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.

Manufacturer Narrative

Depuy still considers the investigation closed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H6 patient code: no code available (3191) used to capture the device revision or replacement.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 43
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTL., LTD. - 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 3684554
• MDR Text Key: 4296455
• Report Number: 1818910-2014-14566
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,foreign,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2015

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: 05/24/2013
• Device Catalogue Number: 999890143
• Device Lot Number: 2643374
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2015
• Initial Date FDA Received: 03/18/2014
• Supplement Dates Manufacturer Received: Not provided; 09/03/2020
• Supplement Dates FDA Received: 06/03/2015; 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR IMPLANT 48; CORAIL2 STD SIZE 12; TAPER SLEEVE ADAPTER 12/14 +2
• Patient Outcome(s): Required Intervention