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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 Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Event Date 11/09/2017
Event Type  Injury  
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. Occupation. Is a non-healthcare professional. (b)(4).
 
Event Description
Asr medical records received. After review of medical records, the patient was revised to address pain and metal wear of asr implants. The hip was aspirated and clear fluid was sent for cell count which was negative for acute inflammation. Tissues were sent for testing and again, was negative for acute inflammation. The tissues were noted to have the appearance of a foreign body reaction consistent with metal debris. There was some black staining of the trunnion consistent with metal corrosion. There was little to no bony ingrowth on the cup. Doi: (b)(6) 2008. Dor: (b)(6) 2017. (left hip).
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive. Further investigation of this individual incident will not be undertaken. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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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
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6103142063
MDR Report Key9416090
MDR Text Key185224474
Report Number1818910-2019-120658
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 11/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL AUGMENT
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/05/2019 Patient Sequence Number: 1
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