MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TOTAL ASR FEM IMP SIZE 46; HIP FEMORAL HEAD

Catalog Number 999803946

Device Problem Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Tissue Damage (2104); Not Applicable (3189)

Event Date 05/13/2016

Event Type  Injury  

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.(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

Patient underwent a revision to address alval/soft tissue reaction and noise.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary 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.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.Device history lot.Null.Device history batch.Null.Device history review.Null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint description: asr revision asr resurfacing right reason(s) for revision: alval / soft tissue reaction and noise.Doi: (b)(6) 2005; dor: (b)(6) 2016; right hip.Update mar 23, 2018 additional information received from (b)(6) as per review of the new information there is no update to the pc.

• Brand Name: TOTAL ASR FEM IMP SIZE 46
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 5780047
• MDR Text Key: 49093192
• Report Number: 1818910-2016-22826
• 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: consumer,foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

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: Health Professional
• Device Expiration Date: 11/13/2008
• Device Catalogue Number: 999803946
• Device Lot Number: 1150783
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention