MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6226-2-644
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The following has been reported: adverse event that occurred in join study case (awa-68).(b)(6), 2018: bha performed.(b)(6), 2018: early postoperative infection was confirmed.Cleaning and revision of inner head and bipolar cup was performed.Stem preserved.(b)(6), 2019: patient's outcome was confirmed as "recovery".
Additional 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.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.Catalog numbers and lot codes of other devices listed in this report: 6720-0435 size 4 accolade ii 132 deg lot 66336203, 6260-5-126 v40 cocr head 26mm/0 lot 66903602.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Additional Manufacturer Narrative
This report, 0002249697-2023-00192 was found to be a duplicate of mfr report # 0002249697-2019-01386.All data for this patient's experience will be captured under mfr report # 0002249697-2019-01386.This product inquiry is being closed as a duplicate.
Event or Problem Description
This report, 0002249697-2023-00192 was found to be a duplicate of mfr report # 0002249697-2019-01386.All data for this patient's experience will be captured under mfr report # 0002249697-2019-01386.This product inquiry is being closed as a duplicate.The following has been reported: adverse event that occurred in join study case ((b)(4)).(b)(6), 2018: bha performed.(b)(6), 2018: early postoperative infection was confirmed.Cleaning and revision of inner head and bipolar cup was performed.Stem preserved.(b)(6), 2019: patient's outcome was confirmed as "recovery".

• Brand Name: CENTRAX DURATION 26MM X 44MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16442177
• Report Number: 0002249697-2023-00192
• Device Sequence Number: 5860498
• Product Code: JDI
• UDI-Device Identifier: 07613327032178
• UDI-Public: 07613327032178
• 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
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: 6226-2-644
• Device Catalogue Number: 6226-2-644
• Device Lot Number: 2J4E2X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 35 KG