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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 45MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 45MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Model Number 6226-2-645
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Codes Inflammation (1932); Pain (1994)
Date of Event 03/10/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event or Problem Description
On (b)(6) 2015 the first tha procedure was performed.The patient complained of pain from around (b)(6) 2021.On (b)(6) 2021 revision was performed for suspicion of metallosis due to wear of polyethylene from centrax.Please investigate the degree of polyethylene wear.
 
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Brand Name
CENTRAX DURATION 26MM X 45MM
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key11632148
Report Number0002249697-2021-00630
Device Sequence Number3396706
Product Code JDI
UDI-Device Identifier07613327032192
UDI-Public07613327032192
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K972792
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number6226-2-645
Device Catalogue Number6226-2-645
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/10/2021
Initial Report FDA Received Date04/07/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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