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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 18D-LRG S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

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DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZT HA 18D-LRG S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 550149
Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 06/02/2020
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
The patient was in pain and had developed a limp. Primary implant date: (b)(6) 2005. Revising a pinnacle asr/srom the surgeon discovered the neck (36 + 12mm) had bent and disconnected from the stem. The original plan was to replace the liner and head from metal on metal articulation to a poly/ceramic or ceramic/ceramic. After opening the surgeon noted that the stem was loose. The neck of the srom stem was disconnected from the stem and sleeve. They replaced the stem with a sized 11 corail kho. The surgeon was able to pull it out with his hand. Rep present. Male patient, id: (b)(6), dob: (b)(6). No delay in the surgery.
 
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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 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10155105
MDR Text Key195168672
Report Number1818910-2020-13803
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,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number550149
Device Lot Number1209752
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2005
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: 06/15/2020 Patient Sequence Number: 1
Treatment
S-ROM*STM STD,30 NK,18X13X160; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD
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