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

Model Number	723-00-36F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Patient reported primary surgery on (b)(6) 2022 and reported 3 left hip dislocations with the most recent on (b)(6) 2022.Patient would like to know if parts are subject to a recall.Patient indicated he is in the process of retaining an attorney.(b)(6) 2022: 1st dislocation (approx), (b)(6) 2022: 2nd dislocation (approx), (b)(6) 2022: 3rd dislocation (approx), each dislocation was treated to "pop back in", nothing was removed.This is for dislocation reduction on (b)(6) 2022.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were provided for review with clinical consultant.-device 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 3 other similar events for the reported lot.They relate to dislocation for the same device/patient, therefore no further trending is required for this commonality.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as 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.It is also noted that the patient is inquiring if the devices are part of a recall.Based on the catalog and lot codes provided the devices reported as not subject to a recall.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.
Event or Problem Description
Patient reported primary surgery on (b)(6) 2022 and reported 3 left hip dislocations with the most recent on (b)(6) 2022.Patient would like to know if parts are subject to a recall.Patient indicated he is in the process of retaining an attorney.(b)(6) 2022: 1st dislocation (approx).(b)(6) 2022: 2nd dislocation (approx).(b)(6) 2022: 3rd dislocation (approx).Each dislocation was treated to "pop back in", nothing was removed.This is for dislocation reduction on (b)(6) 2022.

• Brand Name: TRIDENT 0 DEG 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14691885
• Report Number: 0002249697-2022-00832
• Device Sequence Number: 6778477
• Product Code: LPH
• UDI-Device Identifier: 07613327342239
• UDI-Public: 07613327342239
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

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: 723-00-36F
• Device Catalogue Number: 723-00-36F
• Device Lot Number: MD0AD7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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: Other; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 100 KG