MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 45MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6226-2-645
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Jaundice (2187); Insufficient Information (4580)
Date of Event	01/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.The following devices were also listed in this report: size 3 accolade ii 127 deg; 6721-0330 ; 57478802.26mm std v40 taper vit head; 6260-5-126 ; 55583705.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
This event is about a patient registered for join research.The study was discontinued due to worsening general condition triggered by jaundice and acute cholecystitis.

• 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 Key: 11348322
• Report Number: 0002249697-2021-00307
• Device Sequence Number: 14464279
• Product Code: JDI
• UDI-Device Identifier: 07613327032192
• UDI-Public: 07613327032192
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K972792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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 Expiration Date: 01/31/2021
• Device Model Number: 6226-2-645
• Device Catalogue Number: 6226-2-645
• Device Lot Number: 6R4HX7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/19/2021
• 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
• Patient Weight: 38