MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER54E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	702-04-54E
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.Device not returned to the manufacturer.
Event or Problem Description
Spoke to rep.Patient's left hip was revised due to loosening of the shell.The shell, liner, head and sleeve were revised to competitor acetabular components, and another stryker head and sleeve.Rep confirmed there are no allegations against the revised head, sleeve, or liner.
Additional Manufacturer Narrative
An event regarding loosening involving a trident ii shell was reported.The event was not confirmed.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: the photos present a recent explanted shell, liner and femoral head.Bone tissue/ ingrowth was noticed on the device.There is nothing else remarkable to report.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to loosening of the shell.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 primary 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
Spoke to rep.Patient's left hip was revised due to loosening of the shell.The shell, liner, head and sleeve were revised to competitor acetabular components, and another stryker head and sleeve.Rep confirmed there are no allegations against the revised head, sleeve, or liner.Update (b)(6) 2022 as per sales rep: patient's left hip was revised due to loosening of the shell.The shell, liner, head and sleeve were revised to competitor acetabular components, and another stryker head and sleeve.Rep confirmed there are no allegations against the revised head, sleeve, or liner.Rep reported that explant pictures can be provided, and that no further information will be released by the hospital or surgeon.

• Brand Name: TRIDENTII TRITANIUM CLUSTER54E
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13222692
• Report Number: 0002249697-2022-00060
• Device Sequence Number: 14634465
• Product Code: LPH
• UDI-Device Identifier: 07613327344073
• UDI-Public: 07613327344073
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: 08/31/2023
• Device Model Number: 702-04-54E
• Device Catalogue Number: 702-04-54E
• Device Lot Number: 66916301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2018
• 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: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 250 KG