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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 Device Dislodged or Dislocated (2923)
Patient Problems Fall (1848); Joint Dislocation (2374); Ambulation Difficulties (2544)
Event Date 12/01/2020
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.
 
Event Description
It was reported that the patient's left hip was revised due to dissociation of the femoral head from the adm/ mdm poly insert. Cause of dissociation reported as the patient falling 15 feet from a tree stand while hunting. The poly insert and femoral head were revised to another poly insert and femoral head with sleeve.
 
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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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
joanne mahony
ida industrial estate
carrigtwohill, NJ NA
EI   NA
2018315000
MDR Report Key11054240
MDR Text Key223168837
Report Number0002249697-2020-02738
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 health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/22/2021
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 Expiration Date10/31/2021
Device Model Number1236-2-848
Device Catalogue Number1236-2-848
Device Lot Number57352001
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 Received01/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2016
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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