MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	623-00-40E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fungal Infection (2419)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Tha for left hip of the patient was performed at another hospital on (b)(6) 2012.Because the hospital performed primary tha was closed, the patient took the follow-up at the reported hospital and revision surgery to replace the liner and the head was performed on (b)(6) 2024 because of fungal infection.However, symptoms of infection worsen and the re-revision surgery to remove all tha implant devices was performed on (b)(6) 2024.This record was opened for the revision surgery on (b)(6) and another pi was opened for the revision surgery on (b)(6).
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.The following devices were also listed in this report: device name#: v40 cocr lfit head 40mm/-4; cat#: 6260-9-040; lot# mkljn3.Device name#: accolade plus tmzf hip stem #: 0; cat#: 6021-0030; lot#: 35048704.Device name#: trident psl with purefix ha 52mm; cat#: 542-11-52e; lot#: 37939501.Device name#: 6.5 cancellous bone screw 16mm; cat#: 2030-6516-1; lot#: mkplnp.Device name#: 6.5 cancellous bone screw 20mm; cat#: 2030-6520-1; lot#: mkn3nx.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: TRIDENT 0 DEG INSERT 40MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20404188
• Report Number: 0002249697-2024-01385
• Device Sequence Number: 17748123
• Product Code: LZO
• UDI-Device Identifier: 07613327025323
• UDI-Public: 07613327025323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2024

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: 08/31/2016
• Device Catalogue Number: 623-00-40E
• Device Lot Number: MKMT0K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2011
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian