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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE +5 HEMI HIP IMPLANT : HIP FEMORAL AUGMENT

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DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE +5 HEMI HIP IMPLANT : HIP FEMORAL AUGMENT Back to Search Results
Model Number 1363-12-000
Device Problem Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/01/2021
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 revised to address loosening of the stem at the cement to implant interface. Cement manufacturer is unknown. Patient had an alval on the side of her hip leading the surgeon to believe that the hip prosthesis was having micromotion causing some metal wear. Originally implants were a cobalt chrome summit cemented stem with a cobalt chrome spacer and monopolar hemi arthroplasty head. She was revised to a total hip with a pinnacle cup, altrx liner, screw, corail revision, and delta ceramic head. Lack of metalosys in joint but raised ion levels pre op. Doi: (b)(6) 2018, dor: (b)(6) 2021, affected side: unknown hip.
 
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Brand NameTAPERED SPACER ARTICUL/EZE +5
Type of DeviceHEMI HIP IMPLANT : HIP FEMORAL AUGMENT
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 dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12513546
MDR Text Key272746717
Report Number1818910-2021-20778
Device Sequence Number1
Product Code LZY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K903084
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 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1363-12-000
Device Catalogue Number136312000
Device Lot NumberHP9952
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 Received10/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2018
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: 09/22/2021 Patient Sequence Number: 1
Treatment
CEMENTRALIZER 8.5MM; MODULAR CATHCART BALL 44MM OD; SUMMIT CEMENTED STEM SZ2 STD; TAPERED SPACER ARTICUL/EZE +5
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