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

Catalog Number	508-11-62G
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348); Hip Fracture (2349); Inadequate Osseointegration (2646)
Date of Event	08/09/2019
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.Device not returned.
Event or Problem Description
Revision of right hip acetabulum due to implant loosening with periprosthetic acetabular fracture.Update 09/august/2019 wg: an acetabular shell and 3 screws were reported revised.
Event or Problem Description
Revision of right hip acetabulum due to implant loosening with periprosthetic acetabular fracture.Update 09/august/2019 wg: an acetabular shell and 3 screws were reported revised.
Additional Manufacturer Narrative
An event regarding loosening & periprosthetic fracture involving a trident shell was reported.The event was confirmed by medial review of the provided records.Method & results: device evaluation and results: visual inspection: the reported device was returned for analysis.The shell was returned with the liner inside it and 3 screws protruding from it.There was slight damage identified on the shell surface.Overall there was nothing else remarkable to report.Dimensional & functional inspection: not performed as these aspects are not in question.Material analysis not performed as this event does not relate to material integrity.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: x-ray shows dislocated hip with loose acetabular component with medial acetabular wall fracture and prostusio on the right with broken screws; need additional information; primary and revision operative reports (only admission notes provided), clinical and past medical history, post op x- rays and examination of explanted components.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: x-ray shows dislocated hip with loose acetabular component with medial acetabular wall fracture and prostusio on the right with broken screws; the exact cause of the event could not be determined because insufficient information was provided.Additional information including additional information; primary and revision operative reports (only admission notes provided), clinical and past medical history, post op x- rays and examination of explanted components are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.

• Brand Name: TRIDENT HEMISPHERICAL MULTI
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8964643
• Report Number: 0002249697-2019-03091
• Device Sequence Number: 2150734
• Product Code: MEH
• UDI-Device Identifier: 04546540432254
• UDI-Public: 04546540432254
• Combination Product (Y/N): N
• Initial Reporter State: VI
• Initial Reporter Country: AU
• PMA/510(K) Number: K013676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/18/2019

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: 02/28/2022
• Device Catalogue Number: 508-11-62G
• Device Lot Number: 50736101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 12/18/2019
• 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: 71 YR
• Patient Weight: 110