MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM MULTI 52E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	709-04-52E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
As reported: patient came to the or with a visibly rotated acetabular component.The component was removed and a new acetabular component was placed with extensive screw fixation and mdm bearing was chosen." any complicating conditions notes "initial fracture of the medial wall of the acetabulum." update: "there was a deficient medial wall prior to the initial surgery, which was revised to a multi hole shell, which was then revised to another multi hole shell.2 revisions, this being the second.Initial surgery (b)(6) 2018, initial revision (b)(6) 2018.No allegations or product deficiency.Revision due to patient condition/poor bone quality.".

• Brand Name: TRIDENTII TRITANIUM MULTI 52E
• 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: 10395742
• Report Number: 0002249697-2020-01646
• Device Sequence Number: 3528970
• Product Code: LPH
• UDI-Device Identifier: 07613327344011
• UDI-Public: 07613327344011
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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: 07/31/2023
• Device Model Number: 709-04-52E
• Device Catalogue Number: 709-04-52E
• Device Lot Number: 66597001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/12/2020
• 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: 85 YR
• Patient Weight: 91