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

Catalog Number	690-00-28G
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2023
Type of Reportable Event	Serious Injury
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.H3 other text : device not returned to the manufacturer.
Event or Problem Description
This patient has been revised multiple times due to dislocation.The dislocation that was revised today was due to the constrained liner disassociating from the cup.It was discovered that the bipolar head was frozen inside the constrained insert.There was mobility between the competitor head and the bipolar portion but there was not mobility between the bipolar and the constrained insert.The constrained implant was removed and an mdm was placed.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a trident liner was reported.The event was confirmed.Method & results) product evaluation and results: visual inspection of the returned liner indicates the presence of damage consistent with explantation.Clinician review: a review of the provided medical records by a clinical consultant indicated: the ap pelvis x-rays dated (b)(6) 2023 show bilateral pressfit thas.The right tha in these x-rays has a constrained acetabular liner.The (b)(6) 2023 ap pelvis x-ray demonstrates that the right hip has dislocated.The acetabular constrained liner, along with the head and stem has dislocated from the shell.It is confirmed the patient had a tha with constrained liner and that this liner dissociated from the acetabular component in a tha dislocation.These findings are consistent with recurrent instability.The root cause for the recurrent instability cannot be ascertained from this limited documentation.Device history review: review of the device history records indicate 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 disassociation of the liner from the shell.A review of the provided medical records by a clinical consultant indicated: the ap pelvis x-rays dated (b)(6) 2023 show bilateral pressfit thas.The right tha in these x-rays has a constrained acetabular liner.The (b)(6) 2023 ap pelvis x-ray demonstrates that the right hip has dislocated.The acetabular constrained liner, along with the head and stem has dislocated from the shell.It is confirmed the patient had a tha with constrained liner and that this liner dissociated from the acetabular component in a tha dislocation.These findings are consistent with recurrent instability.The root cause for the recurrent instability cannot be ascertained from this limited documentation.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
This patient has been revised multiple times due to dislocation.The dislocation that was revised today was due to the constrained liner disassociating from the cup.It was discovered that the bipolar head was frozen inside the constrained insert.There was mobility between the competitor head and the bipolar portion but there was not mobility between the bipolar and the constrained insert.The constrained implant was removed and an mdm was placed.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17648688
• Report Number: 0002249697-2023-00964
• Device Sequence Number: 12340616
• Product Code: KWZ
• UDI-Device Identifier: 07613327025583
• UDI-Public: 07613327025583
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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: 03/31/2025
• Device Catalogue Number: 690-00-28G
• Device Lot Number: 982190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male