MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 36F; PROSTHESIS, HIP,

Catalog Number	723-00-36F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: tridentii tritanium cluster56f; cat # 702-04-56f; lot # 22171051a; 6.5mm low profile hex screw 40mm; cat # 7030-6540; lot # grra; delta v-40 ceramic head 36/+2,5; cat # 6570-0-536; lot # 18403955; high insignia collared hip stem; cat # 7000-6605; lot # 14956754.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As reported: "rev r tha for infection, doing a single stage revision hip and going back in with restoration modular." rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIDENT 0 DEG X3 INSERT 36F
• Common Device Name: PROSTHESIS, HIP,
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 20509768
• Report Number: 0002249697-2024-01446
• Device Sequence Number: 21093456
• Product Code: JDI
• UDI-Device Identifier: 07613327342239
• UDI-Public: 07613327342239
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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 Catalogue Number: 723-00-36F
• Device Lot Number: 4H4VV7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 124 KG