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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Model Number 1236-2-848
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 03/14/2022
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. The following devices were also listed in this report: modular dual mobility insert; cat#626-00-42e ; lot#73068904. Primary secur-fit plus max #8/14; cat#6054-0814s ; lot#ha6axa. Delta c-taper head 28mm +5; cat#18-2805 ; lot#72455401. Tridentii tritanium solid 52e; cat#700-04-52e; lot#71575501a. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Event Description
Pt experiencing pain in right hip. Revision total hip.
 
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Brand NameRESTORATION ADM X3 INS 28/48
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
EI NA
Manufacturer Contact
arokiya raj
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14029822
MDR Text Key289670084
Report Number0002249697-2022-00480
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093644
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1236-2-848
Device Catalogue Number1236-2-848
Device Lot Number73528901
Was Device Available for Evaluation? No
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/16/2019
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: 04/06/2022 Patient Sequence Number: 1
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