MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL MULTI; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	508-11-56F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Product not returned.
Event or Problem Description
The patient underwent surgery on (b)(6) 2021 for the placement of stryker products (torx & trident).On (b)(6) 2021 , she was admitted to the hospital for a dislocation.When performing x-ray, she observed stryker product failure.The patient undergoes urgent revision surgery.

• Brand Name: TRIDENT HEMISPHERICAL MULTI
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12030828
• Report Number: 0002249697-2021-01050
• Device Sequence Number: 923346
• Product Code: LPH
• UDI-Device Identifier: 04546540432223
• UDI-Public: 04546540432223
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2021

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: 09/30/2024
• Device Model Number: 508-11-56F
• Device Catalogue Number: 508-11-56F
• Device Lot Number: 73427001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention