MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT X3 ECCENTRIC 10° 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	663-10-36F
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
As reported: "right side hip revision, all components explanted were stryker components.The patient was re-implanted with all new revision components, and the case sheet is attached.The original surgery was done in 2011, the patient recently was reporting pain in his right hip, x-rays showed eccentric wear on the polyethylene component, as well as the femoral head on the trunnion.The patient¿s cobalt chrome levels were elevated, so the surgeon decided to revise the hip component.Adverse local tissue reactions were minimal, however the femoral head did have corrosion and fretting was noted on the trunnion.A portion of the superior lip of the polyethylene liner was fractured off.The locking mechanism was intact on the polyethylene/acetabular component junction, and the liner was not disassociated from the acetabular component.All components were removed." update: the shell was revised because the surgeon didn't like the position of the component.The damaged portion of the liner was the portion that had the lot code on it therefore it was illegible.
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.
Event or Problem Description
As reported: "right side hip revision, all components explanted were stryker components.The patient was re-implanted with all new revision components.The original surgery was done in 2011, the patient recently was reporting pain in his right hip, x-rays showed eccentric wear on the polyethylene component, as well as the femoral head on the trunnion.The patient¿s cobalt chrome levels were elevated, so the surgeon decided to revise the hip component.Adverse local tissue reactions were minimal, however the femoral head did have corrosion and fretting was noted on the trunnion.A portion of the superior lip of the polyethylene liner was fractured off.The locking mechanism was intact on the polyethylene/acetabular component junction, and the liner was not disassociated from the acetabular component.All components were removed." update: the shell was revised because the surgeon didn't like the position of the component.The damaged portion of the liner was the portion that had the lot code on it therefore it was illegible.

• Brand Name: TRIDENT X3 ECCENTRIC 10° 36MM ID
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13202873
• Report Number: 0002249697-2022-00041
• Device Sequence Number: 4257474
• Product Code: LPH
• UDI-Device Identifier: 07613327024913
• UDI-Public: 07613327024913
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2022

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 Model Number: 663-10-36F
• Device Catalogue Number: 663-10-36F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 75 YR
• Patient Sex: Male