MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM MULTI 56F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	709-04-56F
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	10/14/2021
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
As reported: "patient was enrolled in trident ii revision outcomes study.Patient states there is a lot of muscle pain around the hip area, using a cane to walk but is limited by ankle pain and swelling." clinic notes indicate: "loosening of hip joint prosthesis.Mechanical loosening of internal left hip prosthetic joint.Wear of articular bearing surface of internal prosthetic left hip joint".
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident shell was reported.The event was not confirmed.Method & results:  -device evaluation and results: not performed as the device remains implanted.-clinician review: a review of medical records by a clinical consultant indicated: "the patient underwent a revision operation and then developed drainage which required another surgery and liner and head exchange.Subsequent cultures were positive for infection.I can confirm that the debridement and the liner and head exchange took place since i was able to review the operation report and pathology reports.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of drainage and infection following total hip hyperplastic are multifactorial including surgical technique factors and patient factors." -device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.   -complaint history review: there have been no other similar events for the reported lot.  conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pre and post operative xrays are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.
Event or Problem Description
As reported: "patient was enrolled in trident ii revision outcomes study.Patient states there is a lot of muscle pain around the hip area, using a cane to walk but is limited by ankle pain and swelling." clinic notes indicate: "loosening of hip joint prosthesis.Mechanical loosening of internal left hip prosthetic joint.Wear of articular bearing surface of internal prosthetic left hip joint.".

• Brand Name: TRIDENTII TRITANIUM MULTI 56F
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14160659
• Report Number: 0002249697-2022-00551
• Device Sequence Number: 16876801
• Product Code: LPH
• UDI-Device Identifier: 07613327343977
• UDI-Public: 07613327343977
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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: 02/28/2025
• Device Model Number: 709-04-56F
• Device Catalogue Number: 709-04-56F
• Device Lot Number: 76211501A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White