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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Model Number 1236-2-852
Device Problem Insufficient Information (3190)
Patient Problem Bacterial Infection (1735)
Event Date 09/29/2020
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. The following devices were also listed in this report: delta v-40 ceramic head 28/-2,7 cat# 6570-0-328; lot#74257902. Size 5 accolade ii 132 deg cat# 6720-0535; lot#78367317. Modular dual mobility insert cat# 626-00-46f; lot# 75653404. Tridentii tritanium cluster58f cat# 702-04-58f; lot# 77385101a. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Device not returned.
 
Event Description
As reported: "left hip revision due to superficial infection to rule out deep wound infection not related to implants according to dr. " an adm/ mdm poly insert and biolox femoral head were revised. Rep provided the primary usage sheet and confirmed that no further information will be released.
 
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Brand NameRESTORATION ADM X3 INS 28/52
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
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key10730763
MDR Text Key213073983
Report Number0002249697-2020-02231
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
Reporter Occupation
Type of Report Initial
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1236-2-852
Device Catalogue Number1236-2-852
Device Lot Number79339301
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 Received09/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2020
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: 10/23/2020 Patient Sequence Number: 1
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