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

Catalog Number	702-04-54E
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
Corrected data: d10/h3 - the trident shell was not returned to stryker additional manufacturer narrative: reported event: an event regarding disassociation involving a trident shell was reported.The event was not confirmed.Method & results: -device evaluation and results: 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.H3 other text : device not available.
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: 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
• MDR Report Key: 8664408
• Report Number: 0002249697-2019-02137
• Device Sequence Number: 2118106
• Product Code: LPH
• UDI-Device Identifier: 07613327344073
• UDI-Public: 07613327344073
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• 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): 08/14/2019

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: 01/31/2024
• Device Catalogue Number: 702-04-54E
• Device Lot Number: 69580701A
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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: 124