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

Catalog Number 999803946

Device Problem Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Tissue Damage (2104)

Event Date 08/14/2014

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.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, left.Reason(s) for revision: unknown.Update (b)(6) 2018: additional information received from crawford.Reason(s) for revision: multiple reasons.No new information can be obtained from the update.Doi: (b)(6) 2008; dor; (b)(6) 2014; left hip.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 46
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7247735
• MDR Text Key: 99213946
• Report Number: 1818910-2018-52953
• 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: foreign,health professional,o
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2018

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: 08/27/2012
• Device Catalogue Number: 999803946
• Device Lot Number: 2450257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 02/09/2018; 07/07/2018
• Supplement Dates FDA Received: 02/13/2018; 07/11/2018
• Date Device Manufactured: 08/31/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention