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	03/24/2022
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
This pi is for dislocation reduction on march 24, 2022.Patient reported primary surgery on (b)(6) 2022 and reported 3 left hip dislocations with the most recent on (b)(6) 2022.March 24, 2022: 1st dislocation (approx).On (b)(6) 2022: 2nd dislocation (approx).On (b)(6) 2022: 3rd dislocation (approx).Each dislocation was treated to "pop back in", nothing was removed.
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 the 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 related 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
This pi is for dislocation reduction on (b)(6), 2022.Patient reported primary surgery on (b)(6) 2022 and reported 3 left hip dislocations with the most recent on (b)(6).2022.(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.

• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14800077
• Report Number: 0002249697-2022-00914
• Device Sequence Number: 20286779
• 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): 08/31/2022

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: 05/31/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 100 KG