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

Catalog Number	690-10-22E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/06/2019
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Rep reported "patient implanted with 10* trident constrained acetabular liner with 22mm/0+ inner head.Liner disassociated from shell upon patient transfer from surgical table to hospital bed, post anesthesia wakeup and site closure.Patient had to be reinduced and re-opened for immediate revision.Constrained liner and inner head were revised to new implants; surgeon requested that primary implants be investigated.Update: "no allegations against the head; surgeon question locking mechanism." right side.
Additional Manufacturer Narrative
An event regarding disassociation involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: implantation/explantation damage was observed on the proximal and distal surface of the poly inserts as well as the distal rim of the metal head, no materials or manufacturing defects were observed on the surfaces examined.Dimensional & functional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis material evaluation was completed and indicated the following comments: implantation/explantation damage was observed on the proximal and distal surface of the poly inserts as well as the distal rim of the metal head, no materials or manufacturing defects were observed on the surfaces examined.Not performed as product was not returned -clinician review: a review of the provided medical records by a clinical consultant stated the following comment: need operative reports, office/clinical reports, examination of components, etc.-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: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, office/clinical reports, examination of components, etc.Are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Rep reported "patient implanted with 10* trident constrained acetabular liner with 22mm/0+ inner head.Liner disassociated from shell upon patient transfer from surgical table to hospital bed, post anesthesia wakeup and site closure.Patient had to be reinduced and re-opened for immediate revision.Constrained liner and inner head were revised to new implants; surgeon requested that primary implants be investigated.Update: "no allegations against the head; surgeon question locking mechanism." right side.

• Brand Name: TRIDENT CONSTRAINED INSERT
• 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: 8658163
• Report Number: 0002249697-2019-02133
• Device Sequence Number: 16616688
• Product Code: KWZ
• UDI-Device Identifier: 07613327024289
• UDI-Public: 07613327024289
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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: 10/31/2021
• Device Catalogue Number: 690-10-22E
• Device Lot Number: WM36MW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 08/19/2019
• 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: 78 YR
• Patient Weight: 56