MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER56F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	702-04-56F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: size 7 accolade ii 127 deg; cat # 6721-0737; lot # 97197207 delta v-40 ceramic head 28/0; cat # 6570-0-128; lot # 94455602 restoration adm x3 ins 28/52; cat # 7236-2-852; lot # 91721901 6.5mm low profile hex screw 35mm; cat # 7030-6535; lot # xjba.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.
Event or Problem Description
Pt called and wanted to know if the implants had cobalt / any recalls.Had a total hip replacement a year ago.Additional info.22-8-2024: high cobalt levels.

• Brand Name: TRIDENTII TRITANIUM CLUSTER56F
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20235873
• Report Number: 0002249697-2024-01291
• Device Sequence Number: 8516692
• Product Code: LPH
• UDI-Device Identifier: 07613327344004
• UDI-Public: 07613327344004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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: 702-04-56F
• Device Lot Number: 98515701A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2023
• 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: Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Race: White