MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT CONSTRAINED INSERT; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	690-10-22E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left hip was revised due to dissociation of the inner bipolar component from the outer component of a constrained liner.The liner, femoral head, and proximal femur were revised.Rep confirmed there were no allegations against the revised head, and that the surgeon revised the proximal femur only because it was easy to revise prophylactically against infection.
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.The following device were also listed in this report: gmrs prox fem trochanteric lft; cat#: 64951102 ; lot#: unknown.It cannot be determined which, if any of these device may have caused or contributed to the patient's experience.Device not returned to the manufacturer.

• Brand Name: TRIDENT CONSTRAINED INSERT
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: 14506729
• Report Number: 0002249697-2022-00766
• Device Sequence Number: 2558465
• Product Code: KWZ
• UDI-Device Identifier: 07613327024289
• UDI-Public: 07613327024289
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P960047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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: 690-10-22E
• Device Catalogue Number: 690-10-22E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/26/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female