MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-36E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
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 two other similar events for the lot referenced.Same patient.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.Device not returned.
Event or Problem Description
In providing information for legal (b)(6) for a (b)(6)revision on (b)(6) 2020, an operative report was provided indicating the patient had dislocations treated with closed reductions on (b)(6) 2019, and (b)(6) 2020.This pi is for the dislocation and closed reduction on (b)(6) 2019.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a trident liner component was reported.The event was confirmed by medical review.Method & results: - material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: confirmation: a revision surgery was performed for hip instability.Intraoperatively, trunnion corrosion was found.Increased metal levels, device recall, and/or injuries could not be confirmed without additional medical records.Root cause: root cause of the revision was hip instability.The implant position was not felt ideal intraoperatively which would be a primary cause for instability.Abductor and other soft tissue injuries that could lead to hip instability and which would be associated with corrosion products were not documented.Increased metal levels were not established, but if present would be associated with the trunnion corrosion.Records were not provided to establish injuries outside of the revision surgery and history of dislocation.The finding of trunnion corrosion would be associated with an lfit-accolade tmzf problem.-device history review: all 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 reported lot.These were for same patient but previous and subsequent dislocations, no actioned required.Conclusion: the event in this case was confirmed by medical review, the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
In providing information for legal pi for a right hip revision on (b)(6) 2020, an operative report was provided indicating the patient had dislocations treated with closed reductions on (b)(6) 2019, (b)(6) 2019, and (b)(6) 2020.This pi is for the dislocation and closed reduction on (b)(6) 2019.

• Brand Name: TRIDENT 10° 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: 12817620
• Report Number: 0002249697-2021-01895
• Device Sequence Number: 5647333
• Product Code: LPH
• UDI-Device Identifier: 07613327039917
• UDI-Public: 07613327039917
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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: 12/31/2015
• Device Model Number: 623-10-36E
• Device Catalogue Number: 623-10-36E
• Device Lot Number: MJTA18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2010
• 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; Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female