MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-32F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding dislocation involving a trident liner was reported.The event was confirmed vial clinician review.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "represents a male patient, dob (b)(6) described as weighing (b)(6) kg who underwent a right tha on (b)(6) 2018 which was revised on (b)(6) 2020 for recurrent dislocations.On (b)(6) 2018 handwritten brief operative note for a right tha under general anesthesia and a posterior approach.Acetabulum was reamed to 57 for a 58 trident hemispherical shell, 32/10 degree liner, cemented exeter stem.Uncomplicated surgery was noted.Implant labels for the surgery note a #3 exeter v-40 stem with a 32/0 v-40 lfit head were implanted.X-rays on (b)(6) 2020 notes an ap right hip with a hybrid tha.No screws in the acetabular component, reduced and in nominal position.Another ap of the right hip on (b)(6) 2020 shows the hip dislocated with no other changes in the components.No clinical or pmh, no revision operative report or examination of explanted components.Based upon the information available for review, we can confirm at least 1 dislocation of the right tha, but cannot comment on the cause of this clinical event or create a medical report regarding this case." 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: clinician review indicated that we can confirm at least one (1) dislocation of the right tha, but cannot comment on the cause of this clinical event.The exact cause of the event could not be determined because insufficient information was provided.Further information such as clinical or past medical history (pmh), revision operative report 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.Device not returned.
Event or Problem Description
An exeter / trident hip was revised for recurrent dislocation.

• Brand Name: TRIDENT 10° X3 INSERT 32MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9884709
• Report Number: 0002249697-2020-00609
• Device Sequence Number: 11459285
• Product Code: LPH
• UDI-Device Identifier: 07613327039863
• UDI-Public: 07613327039863
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: 09/30/2022
• Device Model Number: 623-10-32F
• Device Catalogue Number: 623-10-32F
• Device Lot Number: A80X2R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/26/2020
• 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: 69
• Patient Weight: 85