MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 28F; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	690-00-28F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.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's hip was revised due to the component disassociation whereby the bipolar head disassociated from the constrained liner.The event could not be confirmed.It was also reported that the constrained liner was implanted with a competitor head, which is determined to be an off-label application.A review of the ifu, noted in warning section that "do not substitute another manufacturer¿s device for any component of the howmedica osteonics total hip system.Any such use will negate the responsibility of howmedica osteonics corp.For the performance of the resulting mixed component implant.[.] " the off-label application is likely contributes to the component disassociation.However, 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
This patient was revised again today (b)(6) 2021.The patient dislocated the bipolar head from the constrained insert.The stryker implants were removed and replaced with competitor devices.Update 19-april-2021 wg: spoke to rep.Left hip.The (inner) bipolar component of the constrained liner dissociated with the outer bearing of the insert.The constrained liner, a shell, and 2 screws were revised to competitor implants.Rep confirmed there are no allegations against the revised shell, it was revised only to convert the patient's hip construct.Rep provided usage sheets and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 28F
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11794890
• Report Number: 0002249697-2021-00817
• Device Sequence Number: 13708241
• Product Code: KWZ
• UDI-Device Identifier: 07613327025552
• UDI-Public: 07613327025552
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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: 12/09/2024
• Device Model Number: 690-00-28F
• Device Catalogue Number: 690-00-28F
• Device Lot Number: VJ72AT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/07/2021
• 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: 57 YR