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	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Pain (1994); Injury (2348); Hip Fracture (2349); Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	01/24/2020
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
Procedure: the patient underwent left total hip arthroplasty (b)(6) 2018.Patient underwent left total hip arthroplasty loosening following acetabular fracture after a fall.Patient underwent revision left total hip arthroplasty, both components changed (b)(6) 2020.
Additional Manufacturer Narrative
Reason for supp: adverse event identified - acetabular fracture and subsequent acetabular component loosening; hazards : none clearly related to implant.Reported event: 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: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: adverse event identified - acetabular fracture and subsequent acetabular component loosening; hazards : none clearly related to implant; conclusion of assessment : the revision surgery, acetabular fracture, and cup loosening were confirmed.Obtaining additional preoperative x-rays may show the progression of the loosening.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: adverse event identified - acetabular fracture and subsequent acetabular component loosening; hazards : none clearly related to implant; conclusion of assessment : the revision surgery, acetabular fracture, and cup loosening were confirmed.Obtaining additional preoperative x-rays may show the progression of the loosening.The event was confirmed.The exact cause of the event could not be determined because insufficient information was provided.Additional information including additional information; device return , 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.
Event or Problem Description
Procedure: the patient underwent left total hip arthroplasty on (b)(6) 2018.Patient underwent left total hip arthroplasty loosening following acetabular fracture after a fall.Patient underwent revision left total hip arthroplasty, both components changed on (b)(6) 2020.

• 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: 10459664
• Report Number: 0002249697-2020-01756
• Device Sequence Number: 2939132
• Product Code: LPH
• UDI-Device Identifier: 04546540432223
• UDI-Public: 04546540432223
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2020

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: 02/28/2023
• Device Model Number: 508-11-56F
• Device Catalogue Number: 508-11-56F
• Device Lot Number: 62356802
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 11/26/2020
• 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: 54 YR
• Patient Weight: 62