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

Model Number	690-00-22D
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
After the surgery trident constrained acetabular liner got failed.The patient has not operated again yet, after the operation, it will be handover to the dealer.
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.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a trident liner was reported.The event was confirmed through clinician review of the provided medical records.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: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the dislocation a total hip replacement with a constrained liner.I can confirm that this event took place since i was able to see an xray with the hip dislocated.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of dislocation of a constrained implant is multifactorial including surgical technique factors, patient activity factors, and less likely implant factors.-product history review: review of the device history records indicate 10 devices were manufactured and accepted into final stock on 13 jan 2021 with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the dislocation a total hip replacement with a constrained liner.I can confirm that this event took place since i was able to see an xray with the hip dislocated.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of dislocation of a constrained implant is multifactorial including surgical technique factors, patient activity factors, and less likely implant factors.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
After the surgery trident constrained acetabular liner got failed.The patient has not operated again yet, after the operation, it will be handover to the dealer.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 22D
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12907209
• Report Number: 0002249697-2021-01988
• Device Sequence Number: 4788612
• Product Code: KWZ
• UDI-Device Identifier: 07613327025538
• UDI-Public: 07613327025538
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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: 11/30/2023
• Device Model Number: 690-00-22D
• Device Catalogue Number: 690-00-22D
• Device Lot Number: NR7M98
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female