MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TOTAL ASR FEM IMP SIZE 45; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999803845

Device Problem Failure to Osseointegrate (1863)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 09/20/2018

Event Type  Injury  

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

Event Description

Reason(s) for revision: pain and loosening of the femoral component.

• Brand Name: TOTAL ASR FEM IMP SIZE 45
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD - 8010379; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7965233
• MDR Text Key: 123702846
• Report Number: 1818910-2018-72512
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2009
• Device Catalogue Number: 999803845
• Device Lot Number: 1172006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2004
• 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