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

Model Number	690-00-22E
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Patient has a trident constrained liner 690-00-22e that has gone in to luxation.The 36mm inner head has 'popped' out of the outer poly-part.The locking ring is intact.Patient.Will get a new operation today.
Event or Problem Description
Patient has a trident constrained liner 690-00-22e that has gone in to luxation.The 36mm inner head has 'popped' out of the outer poly-part.The locking ring is intact.Patient.Will get a new operation today.Update: "the patient is a 75 year old woman.Apart from arthrosis in the left hip she is without pre-existing conditions.She has normal bmi and is extremely active.She was operated (b)(6) 2020 with a primary tha uncemented (trident/corail).The cup was anteverted only about 5-7 degrees.Normal position of the stem.She sustained 3 dislocations of the left hip and was re-operated (b)(6) 2020 changing the standard 10 degree liner to a constrained liner.In association with forced flexion the hip dislocated (b)(6) 2020.The 28mm head was separated from the poly-liner which was still situated in the cup.The locking ring was still in place.During re-operation (b)(6) i discovered that the locking-ring has widened presumably caused by collision between the neck of the stem and the rim of the polyethylene.The solution was a cemented constrained liner in the existing cup in correct anteversion.There seems to be a problem with the trident constrained liner being that the locking ring is too thin.It is impossible to avoid collision between the neck of the stem and the polyethylene in these patients.They are not able to stay within safe limits in rom.When the locking-ring expands the small 28mm head can easily dislocate.".
Additional Manufacturer Narrative
Reported event an event regarding disassociation involving a trident liner was reported.The event was confirmed via product evaluation.Method & results: product evaluation and results: visual inspection of the returned device noted the following: device was returned in used condition.The bipolar device was observed to be separated into its two components, uhmwpe liner and outer femoral head, confirming the reported disassociation event.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: device was returned in used condition.The bipolar device was observed to be separated into its two components, uhmwpe liner and outer femoral head, confirming the reported disassociation event.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, 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.If additional information becomes 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: 10740217
• Report Number: 0002249697-2020-02249
• Device Sequence Number: 16942954
• Product Code: KWZ
• UDI-Device Identifier: 07613327025545
• UDI-Public: 07613327025545
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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 Model Number: 690-00-22E
• Device Catalogue Number: 690-00-22E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 12/13/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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: 75 YR