MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-32D
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not returned.
Event or Problem Description
Patient presented with a periprosthetic fracture.Patient presented to have their hip revised and surgeon decided to replace the liner at the same time as there were obvious scratch marks inside the liner.Surgeon used a different company for the stem fixation and left the psl cup in-situ.

• Brand Name: TRIDENT 10 X3 INSERT 32MM ID
• 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: 11010689
• Report Number: 0002249697-2020-02676
• Device Sequence Number: 13641516
• Product Code: LPH
• UDI-Device Identifier: 07613327039849
• UDI-Public: 07613327039849
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: 10/31/2024
• Device Model Number: 623-10-32D
• Device Catalogue Number: 623-10-32D
• Device Lot Number: 6E2A47
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2020
• Initial Report FDA Received Date: 12/15/2020
• 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
• Patient Age: 70 YR