MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 22E; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	690-00-22E
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported by rep: dr.Revised a gmrs total femur due to a disassociated trident constrained liner.The metal bipolar component disassociated from the poly liner" a constrained liner and femoral head were revised.Right hip."the metal bipolar component dislocated from the poly liner, the v40 head did not dislocate from the metal bipolar component.".
Event or Problem Description
As reported by rep: dr.Revised a gmrs total femur due to a disassociated trident constrained liner.The metal bipolar component disassociated from the poly liner" a constrained liner and femoral head were revised.Right hip."the metal bipolar component dislocated from the poly liner, the v40 head did not dislocate from the metal bipolar component.".
Additional Manufacturer Narrative
An event regarding disassociation, involving, trident liner, was reported.The event was confirmed via device evaluation and medical review.Method & results: device evaluation and results: visual inspection: the device was returned in used condition with biological material throughout.The bipolar device was observed to be separated into its two components, uhmwpe liner and outer femoral head, confirming the reported disassociation event.Material analysis: material analysis is not performed as this is not related to material integrity.Damage consistent with explantation.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: confirmation: the event was confirmed there was a dislocation of the constrained ¿bipolar¿ ball and head by report the hip was revised.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the device was returned in used condition with biological material throughout.The bipolar device was observed to be separated into its two components, uhmwpe liner and outer femoral head, confirming the reported disassociation event.A review of the provided medical records by a clinical consultant stated the following comment: confirmation: the event was confirmed there was a dislocation of the constrained ¿bipolar¿ ball and head by report the hip was revised.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 22E
• 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: 10709971
• Report Number: 0002249697-2020-02195
• Device Sequence Number: 3058754
• Product Code: KWZ
• UDI-Device Identifier: 07613327025545
• UDI-Public: 07613327025545
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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 Model Number: 690-00-22E
• Device Catalogue Number: 690-00-22E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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: 67 YR