MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 42MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	6226-2-642
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/26/2018
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat# 6721-0435; size 4 accolade ii 127 deg; lot# 66189301.Cat# 6260-5-026; 26mm -3 v40 taper vit head; lot# 66336504.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Neurovascular disorder on (b)(6) 2018.Treated with ortop.Update april 29, 2021: this event was reported as multicenter results survey at bha and provided by clinical.According to surgeon, neurovascular disorder is related to procedure.But it is unknown if it is related to device or only procedure.It can be ¿causal relationship¿ is unknown, too.

• Brand Name: CENTRAX DURATION 26MM X 42MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11784817
• Report Number: 0002249697-2021-00808
• Device Sequence Number: 4028447
• Product Code: KWY
• UDI-Device Identifier: 07613327032154
• UDI-Public: 07613327032154
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2021

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: 04/30/2023
• Device Model Number: 6226-2-642
• Device Catalogue Number: 6226-2-642
• Device Lot Number: E76JN9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/06/2021
• 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 Age: 77
• Patient Weight: 37