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

Model Number 508-11-56F

Device Problem Loss of Osseointegration (2408)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994); Injury (2348); Hip Fracture (2349); Inadequate Osseointegration (2646); Joint Laxity (4526)

Event Date 01/24/2020

Event Type  Injury  

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 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.

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 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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10459664
• MDR Text Key: 204545375
• Report Number: 0002249697-2020-01756
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540432223
• UDI-Public: 04546540432223
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 62