MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 22E; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	690-00-22E
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Joint Dislocation (2374)
Date of Event	08/29/2019
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.Device not returned.
Event or Problem Description
It was reported that constrained liner revision surgery was performed on (b)(6) 2019.The patient complained of pain and x-ray showed the left side constrained liner was dislocated in a patient body.When the sales rep checked removed product from the patient's body, head and liner were separated.The constrained liner was revised successfully.
Event or Problem Description
It was reported that constrained liner revision surgery was performed on (b)(6) 2019.The patient complained of pain and x-ray showed the left side constrained liner was dislocated in a patient body.When the sales rep checked removed product from the patient's body, head and liner were separated.The constrained liner was revised successfully.
Additional Manufacturer Narrative
An event regarding disassociation involving a trident liner was reported.The event was confirmed based on the provided photos and clinician review.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following:the femoral head and the constrained liner including the bipolar head and the poly liner were explanted and present in the photograph.The bipolar head was disassociated from the poly liner part of the constrained liner, while the femoral head remained to be assembled in the bipolar head part.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: provided implant and x-ray images confirm constrained liner dislocation/disassociation, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the provided photos and clinician review confirmed the reported event.The exact cause of the event could not be determined because insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 22E
• 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: 9130856
• Report Number: 0002249697-2019-03339
• Device Sequence Number: 16756679
• Product Code: KWZ
• UDI-Device Identifier: 07613327025545
• UDI-Public: 07613327025545
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: 11/30/2022
• Device Catalogue Number: 690-00-22E
• Device Lot Number: XV2RNP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 01/07/2020
• 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: 66 YR