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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Model Number 1236-2-854
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 06/19/2020
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. Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. The following devices were also listed in this report: tridentii tritanium cluster60g; cat# 702-04-60g; lot# 70081001a. Modular dual mobility insert; cat# 626-00-48g; lot# 74323801. Delta v-40 ceramic head 28/+4; cat# 6570-0-228; lot# 64377701. Size 9 accolade ii 132 deg; cat# 6720-0937; lot# 69083902. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Event Description
Procedure: patient underwent index tha on (b)(6) 2020. Then the patient had a periprosthetic joint infection, so all components where exchanged in a one stage revision on (b)(6) 2020.
 
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Brand NameRESTORATION ADM X3 INS 28/54
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11059922
MDR Text Key223371052
Report Number0002249697-2020-02752
Device Sequence Number1
Product Code MEH
UDI-Device Identifier04546540639004
UDI-Public04546540639004
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 health professional,other
Reporter Occupation
Type of Report Initial
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1236-2-854
Device Catalogue Number1236-2-854
Device Lot Number462037
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 Received12/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2020
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: 12/22/2020 Patient Sequence Number: 1
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