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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTPILLAR TMZF SIZE 5 RIGHT PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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STRYKER ORTHOPAEDICS-MAHWAH CENTPILLAR TMZF SIZE 5 RIGHT PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number 5353-0-115
Device Problems Fracture (1260); Loss of Osseointegration (2408)
Patient Problems Pain (1994); Inadequate Osseointegration (2646)
Event Date 02/16/2022
Event Type  Injury  
Event Description
Pain, loosening maybe due to metallosis. Neck of removed centpillar was completely broken.
 
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.
 
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Brand NameCENTPILLAR TMZF SIZE 5 RIGHT
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 Key13718400
MDR Text Key286921965
Report Number0002249697-2022-00364
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number5353-0-115
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2022
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: 03/10/2022 Patient Sequence Number: 1
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