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

Model Number	690-00-28G
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	07/05/2022
Type of Reportable Event	Malfunction
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.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.
Event or Problem Description
The following was reported: upon range of motion check the flexion and internal rotation of the leg resulted in the large head dissociating from the constrained liner.The two parts of the implant dissociated dislocating the hip.
Additional Manufacturer Narrative
Correction: patients age, date of birth and weight updated.Reported event: an event regarding disassociation involving a trident liner was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection: the liner and head were returned for evaluation.Scratches are visible on the liner consistent with attempted implantation of the device.The liner and head appear unremarkable.Dimensional and functional inspection were not performed as implantation attempts were made and any inspection would not be reflective of its original manufactured state.Material analysis was not performed as disassociation does not relate to material integrity.Clinician review: a review of medical records with a clinical consultant indicated "this inquiry concerns a patient who underwent a primary total hip arthroplasty, developed instability requiring insertion of a constrained liner and then subsequently the constrained liner disassociated requiring another surgery.I can confirm that a primary total hip was performed because i was able to read the operation report and i did see a post-operative x-ray that showed a primary total hip with the appropriate implants.I can also confirm that parts resembling the constrained liner were removed.I will not be able to determine the root cause of these events.The root cause of hip dislocation is multifactorial including surgical technique and patient factors including bmi and activity level.The causes of constrained liner disassociation are also multifactorial including surgical technique such as proper positioning, restoration of leg lengths, the quality of the muscles and capsule surrounding the hip and also patient activities and levels." device history review: review of the device history records indicate the 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.Conclusion: it was reported that the patient was revised due to dislocation, however intraoperatively disassociation of the constrained liner occurred.The liner and head were returned for evaluation.Scratches are visible on the liner consistent with attempted implantation of the device.The liner and head appear unremarkable.A review of medical records with a clinical consultant indicated "this inquiry concerns a patient who underwent a primary total hip arthroplasty, developed instability requiring insertion of a constrained liner and then subsequently the constrained liner disassociated requiring another surgery.I can confirm that a primary total hip was performed because i was able to read the operation report and i did see a post-operative x-ray that showed a primary total hip with the appropriate implants.I can also confirm that parts resembling the constrained liner were removed.I will not be able to determine the root cause of these events.The root cause of hip dislocation is multifactorial including surgical technique and patient factors including bmi and activity level.The causes of constrained liner disassociation are also multifactorial including surgical technique such as proper positioning, restoration of leg lengths, the quality of the muscles and capsule surrounding the hip and also patient activities and levels." no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The following was reported: upon range of motion check the flexion and internal rotation of the leg resulted in the large head dissociating from the constrained liner.The two parts of the implant dissociated dislocating the hip.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 28G
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15111625
• Report Number: 0002249697-2022-01088
• Device Sequence Number: 17196984
• Product Code: KWZ
• UDI-Device Identifier: 07613327025583
• UDI-Public: 07613327025583
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 690-00-28G
• Device Catalogue Number: 690-00-28G
• Device Lot Number: 337433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• 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: Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 90 KG