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

Model Number	690-00-28F
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/14/2022
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
The following was reported: patient fell on his hip.
Event or Problem Description
The following was reported: patient fell on his hip.
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: -device evaluation and results: visual inspection: the devices were returned in used condition.The constrained liner is in a disassembled state: the uhr bipolar head is detached from the outer acetabular poly liner.Visual inspection of the devices noted minor scratches consistent with explantation.A hole from explanted screw observed on the liner.Dimensional and functional inspection were not performed as the device was implanted and subsequently explanted.The device in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis was not performed because the event does not relate to material integrity -clinician review:¿a review of the provided medical records by a clinical consultant stated the following comment: "this patient underwent a primary total hip arthroplasty using a constrained liner.Approximately two weeks after surgery the patient fell and sustained a dislocation of the inner portion of the construct.I can confirm that this event occurred since i was able to review the x-ray with the dislocation.I cannot determine the root cause of this event with certainty.Causes of intra-prosthetic dislocation are multifactorial including trauma, surgical technique, including proper assembly and impaction, patient factors and implant factors." -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 reported lot.  conclusion: a review of the provided medical records by a clinical consultant stated the following comment: "this patient underwent a primary total hip arthroplasty using a constrained liner.Approximately two weeks after surgery the patient fell and sustained a dislocation of the inner portion of the construct.I can confirm that this event occurred since i was able to review the x-ray with the dislocation.I cannot determine the root cause of this event with certainty.Causes of intra-prosthetic dislocation are multifactorial including trauma, surgical technique, including proper assembly and impaction, patient factors and implant factors." 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 28F
• 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: 15048614
• Report Number: 0002249697-2022-01032
• Device Sequence Number: 4784469
• Product Code: KWZ
• UDI-Device Identifier: 07613327025552
• UDI-Public: 07613327025552
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2022

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: 08/31/2026
• Device Model Number: 690-00-28F
• Device Catalogue Number: 690-00-28F
• Device Lot Number: 594HM4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 10/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 75 KG