MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 32H; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	690-00-32H
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/14/2022
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.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
Constrained liner dislocation type iii or iv on (b)(6).Revision done (b)(6).Switched out for modular dual mobility.
Event or Problem Description
Constrained liner dislocation type iii or iv on april 13th.Revision done april 14.Switched out for modular dual mobility.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a trident liner was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient had multiple procedures all related to instability.Initially a primary trident liner was utilized, it was then revised to and mdm.The patient then approximately two years later required a revision where the mdm liner was replaced with a constrained insert.That constrained insert dislocated requiring another procedure.Causes of dislocation of a primary total hip are multifactorial but in most cases is surgical technique related possibly due to malposition of implants and failure to restore soft tissue tension.Later dislocation can be due to factors such as trauma and stretching out of the soft tissue envelope around the hip.Causes of dislocation of a constrained liner immediately after surgery may also be surgical technique related in that the liner may not have been properly seated.Another cause could be trauma but none was reported in this case.Regarding the event, i can confirm that a dislocation of the constrained liner occurred since i was able to see an xray showing the dislocation.I have no way to confirm any other event since i have no supporting documentation or x-rays.Regarding the root cause of the event, i believe it is likely that surgical technique played a significant role and for the late dislocation, most likely the soft tissues stretched allowing increased laxity in the joint." -device history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusion: the event of dislocation was confirmed via clinician review of the provided medical records which indicated: this patient had multiple procedures all related to instability.Initially a primary trident liner was utilized, it was then revised to and mdm.The patient then approximately two years later required a revision where the mdm liner was replaced with a constrained insert.That constrained insert dislocated requiring another procedure.Causes of dislocation of a primary total hip are multifactorial but in most cases is surgical technique related possibly due to malposition of implants and failure to restore soft tissue tension.Later dislocation can be due to factors such as trauma and stretching out of the soft tissue envelope around the hip.Causes of dislocation of a constrained liner immediately after surgery may also be surgical technique related in that the liner may not have been properly seated.Another cause could be trauma but none was reported in this case.Regarding the event, i can confirm that a dislocation of the constrained liner occurred since i was able to see an xray showing the dislocation.I have no way to confirm any other event since i have no supporting documentation or x-rays."regarding the root cause of the event, i believe it is likely that surgical technique played a significant role and for the late dislocation, most likely the soft tissues stretched allowing increased laxity in the joint." 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.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 32H
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14350120
• Report Number: 0002249697-2022-00676
• Device Sequence Number: 4077736
• Product Code: KWZ
• UDI-Device Identifier: 07613327025569
• UDI-Public: 07613327025569
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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: 08/31/2025
• Device Model Number: 690-00-32H
• Device Catalogue Number: 690-00-32H
• Device Lot Number: MM4V03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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: 68 YR
• Patient Sex: Female
• Patient Race: White