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 Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	09/29/2020
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
A revision left total hip arthroplasty was performed to replace a constrained liner that had become disengaged from a acetabular cup.A new lfit femoral head and trident constrained liner were utilized.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a trident liner was reported.The event was confirmed via medical review.Method & results: product evaluation and results: visual inspection of the returned device noted the following: device was returned in used condition with signs of wear throughout.No other remarkable observations were noted.Clinician review: a review of the provided medical information by a clinical consultant indicated: x-rays reveal evidence of a displaced liner see screen shot enclosed post operative x-rays show the new cup and constrained liner in expected position.Note is made of an extensive instrumented lumbar fusion.Lumbar fusion is a risk factor for tha instability.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: a review of the provided medical information by a clinical consultant indicated: x-rays reveal evidence of a displaced liner see screen shot enclosed post operative x-rays show the new cup and constrained liner in expected position.Note is made of an extensive instrumented lumbar fusion.Lumbar fusion is a risk factor for tha instability.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports 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.H3 other text : device not returned.
Event or Problem Description
A revision left total hip arthroplasty was performed to replace a constrained liner that had become disengaged from a acetabular cup.A new lfit femoral head and trident constrained liner were utilized.

• 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: 10725081
• Report Number: 0002249697-2020-02214
• Device Sequence Number: 13872939
• Product Code: KWZ
• UDI-Device Identifier: 07613327025538
• UDI-Public: 07613327025538
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: 06/30/2024
• Device Model Number: 690-00-22D
• Device Catalogue Number: 690-00-22D
• Device Lot Number: V407NY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/09/2020
• 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: 71 YR