MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 TOTAL ASR FEM IMP SIZE 45; HIP FEMORAL HEAD

Catalog Number 999803845

Device Problems Loose or Intermittent Connection (1371); Loss of Osseointegration (2408); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Inadequate Osseointegration (2646)

Event Date 05/15/2014

Event Type  Injury  

Event Description

Asr revision; asr resurfacing- right; reason(s) for revision: component (head) loosening, pain, noise, alval.

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

On sept 2015 - update - rcvd (b)(6) legal, added kid number and marked as legal , added exp dates to products.Patient underwent an operation on (b)(6) 2012 for tissue removal - not implant removal.

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

• Brand Name: TOTAL ASR FEM IMP SIZE 45
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 4006872
• MDR Text Key: 20789021
• Report Number: 1818910-2014-25597
• 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,consumer,foreign,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/04/2015

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: 10/12/2009
• Device Catalogue Number: 999803845
• Device Lot Number: 1805204
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2014
• Initial Date FDA Received: 08/13/2014
• Supplement Dates Manufacturer Received: Not provided; 08/07/2018; 08/20/2018
• Supplement Dates FDA Received: 09/15/2015; 08/10/2018; 09/04/2018
• 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