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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 G2 PRESS FIT STEM SZ6L G2 CEMENTED AND CEMENTLESS STEMS : HIP FEMORAL STEM

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DEPUY INTERNATIONAL LTD - 8010379 G2 PRESS FIT STEM SZ6L G2 CEMENTED AND CEMENTLESS STEMS : HIP FEMORAL STEM Back to Search Results
Catalog Number 900000126
Device Problem Loss of Osseointegration (2408)
Patient Problems Bone Fracture(s) (1870); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 06/04/2020
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.
 
Event Description
It was reported that patient fractured left femur. Surgeon removed g2 femoral stem pinnacle liner and femoral head. Surgeon used a long stem to revise. Cup remained implanted. It was also indicated that there was a loosening of the stem at bone to implant interface. Doi: (b)(6) 2003, dor: (b)(6) 2020, affected side: left hip.
 
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Brand NameG2 PRESS FIT STEM SZ6L
Type of DeviceG2 CEMENTED AND CEMENTLESS STEMS : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10160930
MDR Text Key195387790
Report Number1818910-2020-13933
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number900000126
Device Lot Number1058206
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 Received07/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2002
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: 06/17/2020 Patient Sequence Number: 1
Treatment
ARTICUL/EZE BALL 32 +5 BR; G2 PRESS FIT STEM SZ6L; PINN MAR +4 NEUT 32IDX54OD; PINNACLE SECTOR II CUP 54MM
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