MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER44B; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	702-04-44B
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: size 2 accolade ii 127 deg; cat# 6721-0230; lot# 75939801; trident 0 deg x3 insert 32mm id; cat# 623-00-32b; lot# e78r1e; 32mm +8 lfit v40 head; cat# 6260-9-332; lot# 74079903; unknown screw; cat# unknown; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding loosening & infection involving a trident shell was reported.The event was not confirmed.Method & results: -device evaluation and results: the device was not returned for inspection; however, photographs were provided for review.The photographs show a recently explanted shell covered in biologicals material; the liner and a screw are assembled to the shell.-clinician review: no medical records were received for review with a clinical consultant.-device history review: product history review could not be performed as the device lot details were not provided.-complaint history review: a complaint history review could not be performed as the device lot details were not provided.Conclusion: it was reported that the patient was revised due to shell loosening and infection.The device was not returned for inspection; however, photographs were provided for review.The photographs show a recently explanted shell covered in biologicals material; the liner and a screw are assembled to the shell.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes 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.
Event or Problem Description
Revision of primary total hip replacement to a competitor revision hip.Reason for revision is loose cup and infection.Original surgery was in 2020.

• Brand Name: TRIDENTII TRITANIUM CLUSTER44B
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20629935
• Report Number: 0002249697-2024-01520
• Device Sequence Number: 20664608
• Product Code: LPH
• UDI-Device Identifier: 07613327343786
• UDI-Public: 07613327343786
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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 Catalogue Number: 702-04-44B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 56 YR
• Patient Sex: Female