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

Model Number	623-00-36F
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	06/30/2021
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 no other similar events for the lot referenced.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 had left index tha in (b)(6) 2021.Patient presents with recurrent instability.Undergoes revision on (b)(6) 2021.Findings: instability and heterotopic ossification.Only head, and liner are exchanged.
Additional Manufacturer Narrative
Reported event; an event regarding dislocation, instability and patient factors (heterotopic ossification) was reported.The event of patient factors was confirmed.Dislocation and instability was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a right total hip replacement due to recurrent instability approximately three months following the primary surgery.I can confirm that the revision took place since i was able to review an operation report that described the instability and the change of components.I cannot confirm actual dislocation since i have no corroborating evidence such as office notes or x-rays with the hip dislocated.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of recurrent dislocation at approximately three months after the index operation are almost always surgical technique related but could be impacted by patient compliance and other factors.In this case the surgeon reports a 1 inch in diameter heterotopic bone formation as the cause of the dislocation.In my experience that would be unlikely.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 no other similar events for the lot referenced.Conclusion: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a right total hip replacement due to recurrent instability approximately three months following the primary surgery.I can confirm that the revision took place since i was able to review an operation report that described the instability and the change of components.I cannot confirm actual dislocation since i have no corroborating evidence such as office notes or x-rays with the hip dislocated.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of recurrent dislocation at approximately three months after the index operation are almost always surgical technique related but could be impacted by patient compliance and other factors.In this case the surgeon reports a 1 inch in diameter heterotopic bone formation as the cause of the dislocation.In my experience that would be unlikely.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.
Event or Problem Description
Patient had left index tha in march 10, 2021.Patient presents with recurrent instability.Undergoes revision on (b)(6), 2021.Findings: instability and heterotopic ossification.Only head, and liner are exchanged.

• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13630295
• Report Number: 0002249697-2022-00290
• Device Sequence Number: 17597138
• Product Code: LPH
• UDI-Device Identifier: 07613327039535
• UDI-Public: 07613327039535
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 12/31/2024
• Device Model Number: 623-00-36F
• Device Catalogue Number: 623-00-36F
• Device Lot Number: KX1074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2019
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 77 KG