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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZT HA 18F-XXL S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

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DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZT HA 18F-XXL S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 550153
Device Problem Loss of Osseointegration (2408)
Patient Problems Pain (1994); Not Applicable (3189)
Event Date 04/26/2018
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Revision total hip replacement - (b)(6); (b)(6), (b)(6) 2018. Primary implant date: (b)(6) 1999. Reason for revision: thigh pain that has progressed over this year. Patient presented to surgeon with hip thigh pain. Surgeon concluded that a revision hip replacement was required. Removal of s-rom hip was undertaken and revision to zimmer stem was performed. Male patient initials (b)(6), age: (b)(6) years, dob: (b)(6). Unknown_jrn: 18 by 13 by 36+8 s-rom stem
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discarded; unknown_jrn: 18 f extra large sleeve
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discarded; unknown_jrn: 28 +0 chrome cobalt head
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discarded.
 
Manufacturer Narrative
(b)(4). Investigation summary no device associated with this report was received for examination. Depuy considers the investigation closed at this time. 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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Type of DeviceS-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7540583
MDR Text Key109133217
Report Number1818910-2018-60402
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K912713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number550153
Device Lot Number563742
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/03/1999
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: 05/24/2018 Patient Sequence Number: 1
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