MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-00-36E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient suffered a 3rd episode of left thp dislocation during the night of (b)(6) 2022 while getting up from the toilet.Reduction surgery using external maneuvers was performed under general sedation on (b)(6) 2022.
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 other similar events for the reported lot.These events are all for the same device and the same patient, therefore no further trending is required for this commonality.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : not returned to the manufacturer.
Event or Problem Description
The patient suffered a 3rd episode of left thp dislocation during the night of (b)(6) 2022 while getting up from the toilet.Reduction surgery using external maneuvers was performed under general sedation on (b)(6) 2022.
Additional Manufacturer Narrative
An event regarding dislocation involving a trident liner was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection, dimensional, functional and material analysis could not be performed as the device remained implanted.-clinician review: a review of medical records with a clinical consultant indicated " the surgeon's notes confirm a patient with multiple tha dislocations required closed reduction under anesthesia.Following the third manipulation post reduction imaging demonstrated a displaced transverse fracture of the greater trochanter necessitating further surgery to repair the fracture.The root cause of the tha instability leading to multiple reductions of tha dislocation under anesthesia and subsequent trochanteric fracture cannot be established with the limited information provided." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been 2 other similar events for the lot referenced.Both events relate to a similar event for the same device/patient, therefore no further trending is required for this commonality.Conclusions: it was reported that the patient had a reduction by external maneuvers under general anesthesia.A review of medical records with a clinical consultant indicated " the surgeon's notes confirm a patient with multiple tha dislocations required closed reduction under anesthesia.Following the third manipulation post reduction imaging demonstrated a displaced transverse fracture of the greater trochanter necessitating further surgery to repair the fracture.The root cause of the tha instability leading to multiple reductions of tha dislocation under anesthesia and subsequent trochanteric fracture cannot be established with the limited information provided." no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT 0° X3 INSERT 36MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16875690
• Report Number: 0002249697-2023-00484
• Device Sequence Number: 17599941
• Product Code: LPH
• UDI-Device Identifier: 07613327039542
• UDI-Public: 07613327039542
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: 01/31/2016
• Device Model Number: 623-00-36E
• Device Catalogue Number: 623-00-36E
• Device Lot Number: 35871901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 60 KG