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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FINSBURY ORTHOPAEDICS LIMITED ADEPT MODULAR HEAD V40 TAPER 050 OFFSET +0 ADEPT IMPLANT : HIP METAL FEMORAL HEADS

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FINSBURY ORTHOPAEDICS LIMITED ADEPT MODULAR HEAD V40 TAPER 050 OFFSET +0 ADEPT IMPLANT : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 179350
Device Problem Separation Problem
Event Date 07/09/2019
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

On (b)(6) 2019 the patient was revised due to discomfort. X-ray revealed disassociation between femoral head and stem trunnion. Doi: (b)(6) 2009; dor: (b)(6) 2019: right hip.

 
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Brand NameADEPT MODULAR HEAD V40 TAPER 050 OFFSET +0
Type of DeviceADEPT IMPLANT : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
FINSBURY ORTHOPAEDICS LIMITED
13 mole business park,
randall
leatherhead, surrey KT22 7BA
UK  KT22 7BA
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8DT
UK  LS11 8DT
Manufacturer Contact
kara ditty-bovard
1210 ward av
west chester , PA LS11 -8 DT
6107428552
MDR Report Key9075429
Report Number1818910-2019-104867
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Type of Report Initial,Followup
Report Date 08/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number179350
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/17/2019 Patient Sequence Number: 1
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