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

Model Number	623-10-36F
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	02/03/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a trident liner was reported.The event was confirmed through clinician review of the provided medical records.Method & results: device evaluation and results: not performed as product was not returned clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a left total hip replacement performed in 2014 and revised in 2022 for mechanical wear of the polyethylene component, trunnionosis and elevated ion levels.It also reports the failure of a right total hip performed in 2015 and revised in 2020 for elevated ion levels.I can confirm that the revision of the left hip took place since i was able to review the operation report.I cannot confirm that the revision of the right total hip took place since there is no documentation to corroborate the procedure.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of polyethylene wear are multifactorial including surgical technique factors such as impingement, patient activity factors, and implant factors.Causes of elevated ion levels are also multifactorial including surgical technique factors, patient activity factors and implant factors.To confirm trunnionosis due to corrosion a metallurgical analysis must be performed device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a left total hip replacement performed in 2014 and revised in 2022 for mechanical wear of the polyethylene component, trunnionosis and elevated ion levels.It also reports the failure of a right total hip performed in 2015 and revised in 2020 for elevated ion levels.I can confirm that the revision of the left hip took place since i was able to review the operation report.I cannot confirm that the revision of the right total hip took place since there is no documentation to corroborate the procedure.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of polyethylene wear are multifactorial including surgical technique factors such as impingement, patient activity factors, and implant factors.Causes of elevated ion levels are also multifactorial including surgical technique factors, patient activity factors and implant factors.To confirm trunnionosis due to corrosion a metallurgical analysis must be performed if further information becomes available or the product is returned, this investigation will be re-opened.Device not returned.
Event or Problem Description
This pi is for left hip: it was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6), 2014.It is further alleged that he suffered injuries as a result of implantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Patient had not yet scheduled a surgery for explantation of the femoral head at issue.Update: 07 march 2022: based on the medical review: this inquiry reports the failure of a left total hip replacement performed in 2014 and revised in 2022 for mechanical wear of the polyethylene component, trunnionosis and elevated ion levels.

• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 13925279
• Report Number: 0002249697-2022-00440
• Device Sequence Number: 1763532
• Product Code: LPH
• UDI-Device Identifier: 07613327039924
• UDI-Public: 07613327039924
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2022

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 Expiration Date: 01/31/2019
• Device Model Number: 623-10-36F
• Device Catalogue Number: 623-10-36F
• Device Lot Number: MMT967
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2014
• 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