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 Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported that the patient's right hip was revised due to disassociation of the constrained liner completely from the acetabular shell.The constrained liner and competitor head were revised to an mdm liner/ adm insert construct with another competitor head.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation is reported involving trident insert.The event was confirmed by medical review.Method & results: -product evaluation and results: visual inspection - visual inspection of attach images was performed and stated that - explanted damage and blood drops can be observed on the insert surface.Functional, dimensional and material analysis of device could not performed as no device is return for examination.-clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: without medical records or x-rays it is impossible to confirm the assessment with any certainty.Based on the material provided it appears that the liner dissociated from the shell.The anteversion of the cup or stem cannot be assessed.The failure did not occur at the mismatched inner and outer ball but at the intraoperative assembly interface (cup-liner).This was a patient at high risk of dislocation obtaining the implant may be provide insight into the mechanism of failure.Product history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: it was reported that patient right hip was revised due to disassociation.The event was confirmed for disassociation by provided medical review.Visual inspection - visual inspection of attach images was performed and stated that - explanted damage and blood drops can be observed on the insert surface.Without medical records or x-rays it is impossible to confirm the assessment with any certainty.Based on the material provided it appears that the liner dissociated from the shell.The anteversion of the cup or stem cannot be assessed.The failure did not occur at the mismatched inner and outer ball but at the intraoperative assembly interface (cup-liner).This was a patient at high risk of dislocation obtaining the implant may be provide insight into the mechanism of failure.The exact cause of the event could not be determined because lack of information for example: further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to disassociation of the constrained liner completely from the acetabular shell.The constrained liner and competitor head were revised to an mdm liner/ adm insert construct with another competitor head.

• 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
• MDR Report Key: 9979174
• Report Number: 0002249697-2020-00777
• Device Sequence Number: 2089486
• Product Code: KWZ
• UDI-Device Identifier: 07613327025538
• UDI-Public: 07613327025538
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: 05/31/2023
• Device Model Number: 690-00-22D
• Device Catalogue Number: 690-00-22D
• Device Lot Number: H1576E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR