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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, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU Back to Search Results
Catalog Number 1236-2-848
Device Problems Degraded; Material Deformation
Event Date 02/12/2019
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

As reported: "eccentric wear, [an mdm/adm liner construct and femoral head were] revised to 36e x3 liner and ceramic head.

 
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Brand NameRESTORATION ADM X3 INS 28/48
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
evelyn ryan
raheen business park
limerick  NA
61498200
MDR Report Key8413340
Report Number0002249697-2019-01306
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 03/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1236-2-848
Device LOT NumberUNKNOWN
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 Received02/12/2019
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: 03/12/2019 Patient Sequence Number: 1
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