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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910  S-ROM*SLEEVE PRX ZT HA 18D-LRG S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

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DEPUY ORTHOPAEDICS, INC. 1818910  S-ROM*SLEEVE PRX ZT HA 18D-LRG S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 550149
Device Problem Loss of Osseointegration (2408)
Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 01/15/2019
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. (b)(4).
 
Event Description
Revised the patient's hip stem due to loosening.
 
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Type of DeviceS-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
1210 ward avenue, PA 19380
6103142063
MDR Report Key8315611
MDR Text Key135376895
Report Number1818910-2019-83568
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K912713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number550149
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2019
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: 02/07/2019 Patient Sequence Number: 1
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