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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL AUGMENT

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL AUGMENT Back to Search Results
Catalog Number UNK HIP FEMORAL AUGMENT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Anxiety (2328); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(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. No 510(k) number provided because this implant product code was sold internationally. It was sold in the us under a different product code.  .
 
Event Description
Asr revision. Asr xl: unknown hip. Reason for revision: unknown.
 
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Brand NameUNKNOWN HIP FEMORAL AUGMENT
Type of DeviceHIP FEMORAL AUGMENT
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
chad gibson
700 orthopaedic dr.
warsaw, IN 46582
5743725905
MDR Report Key7476334
MDR Text Key107006188
Report Number1818910-2018-58660
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL AUGMENT
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/01/2018 Patient Sequence Number: 1
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