MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6226-2-646
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicates that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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.
Event or Problem Description
It was reported that, during a bha, a surgeon found some fragments of sock on the insert of the centrax.

• Brand Name: CENTRAX DURATION 26MM X 46MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7820066
• Report Number: 0002249697-2018-02681
• Device Sequence Number: 13800889
• Product Code: JDI
• UDI-Device Identifier: 07613327032185
• UDI-Public: 07613327032185
• Combination Product (Y/N): N
• PMA/510(K) Number: K972792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 6226-2-646
• Device Lot Number: KW59YH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other