MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER50D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	702-04-50D
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	08/14/2019
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.
Event or Problem Description
This pi is for the revision of the primary stryker implants on (b)(6) 2019.Patient had a competitor nail in her left femur which was revised to a stryker total hip with robot navigation on (b)(6) 2019.On (b)(6) 2019, it was discovered that the patient's acetabulum had fractured at the posterior wall and posterior column.On 14/august/2019, the surgeon revised the shell, 36d 0° poly liner, and biolox 36 +0 head to a new shell with an adm/ mdm liner construct and another femoral head.Rep confirmed there are no allegations against the liner or femoral head.The restoration modular 23 +0 body had been removed to access the patient's acetabulum, and re-implanted.Possible cause or time of fracture are unknown (or whether it was pre- or post- mako procedure), but during the implantation 12/august/2019, the surgeon reported that the shell felt "incredibly stable" and saw no need to implant supplemental screws.
Additional Manufacturer Narrative
Corrected data: it was discovered that the selection for b2 was inadvertently missed during the submission of the initial report.B2 has been updated with the appropriate information.Device not returned.
Event or Problem Description
This pi is for the revision of the primary stryker implants on (b)(6) 2019.Patient had a competitor nail in her left femur which was revised to a stryker total hip with robot navigation on (b)(6) 2019.On (b)(6) 2019, it was discovered that the patient's acetabulum had fractured at the posterior wall and posterior column.On (b)(6) 2019, the surgeon revised the shell, 36d 0° poly liner, and biolox 36 +0 head to a new shell with an adm/ mdm liner construct and another femoral head.Rep confirmed there are no allegations against the liner or femoral head.The restoration modular 23 +0 body had been removed to access the patient's acetabulum, and re-implanted.Possible cause or time of fracture are unknown (or whether it was pre- or post- mako procedure), but during the implantation (b)(6) 2019, the surgeon reported that the shell felt "incredibly stable" and saw no need to implant supplemental screws.

• Brand Name: TRIDENTII TRITANIUM CLUSTER50D
• 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: 8980909
• Report Number: 0002249697-2019-03153
• Device Sequence Number: 365147
• Product Code: LPH
• UDI-Device Identifier: 07613327344103
• UDI-Public: 07613327344103
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2020

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: 04/30/2024
• Device Model Number: 702-04-50D
• Device Catalogue Number: 702-04-50D
• Device Lot Number: 71220301A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 11/22/2020
• 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: 75 YR