MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 502-01-52E

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding loosening involving a trident shell was reported.The event was confirmed by clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review additional information related to pi including the product inquiry summary, implant record from a revision tha surgery, revision surgery operative report, physical therapy discharge note and an ap x-ray of a failed tha.The event description from the product inquiry summary states: patient had total hip 13 years ago and recently started to experience pain in her hip.The x-ray shows dissociation of the femoral head with deformation of the trunnion.The cup has lost fixation and is now oriented vertically.There is significant peri-acetabular osteolysis.All these findings are further described in the operative report which also mentions significant metallosis throughout the hip.Historically the surgeon notes that the patient had a chronically painful tha which went on to acute failure necessitating revision surgery.It is confirmed that the patient had a revision tha surgery related to failure of the trunnion and head interface with trunnion deformation and head dissociation.In addition, there was loss of fixation of the acetabular component.The root cause of this issue cannot be established by the limited documentation provided.Should additional information become available i would be happy to further this assessment.Product 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 no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review additional information related to pi including the product inquiry summary, implant record from a revision tha surgery, revision surgery operative report, physical therapy discharge note and an ap x-ray of a failed tha.The event description from the product inquiry summary states: patient had total hip 13 years ago and recently started to experience pain in her hip.The x-ray shows dissociation of the femoral head with deformation of the trunnion.The cup has lost fixation and is now oriented vertically.There is significant peri-acetabular osteolysis.All these findings are further described in the operative report which also mentions significant metallosis throughout the hip.Historically the surgeon notes that the patient had a chronically painful tha which went on to acute failure necessitating revision surgery.It is confirmed that the patient had a revision tha surgery related to failure of the trunnion and head interface with trunnion deformation and head dissociation.In addition, there was loss of fixation of the acetabular component.The root cause of this issue cannot be established by the limited documentation provided.Should additional information become available i would be happy to further this assessment.No further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient had total hip 13 years ago and recently started to experience pain in her hip.Update as per med review comment: "the x-ray shows dissociation of the femoral head with deformation of the trunnion.The cup has lost fixation and is now oriented vertically.".

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER 52MM
• Type of Device: 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: 15040302
• MDR Text Key: 296049530
• Report Number: 0002249697-2022-01024
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613153073086
• UDI-Public: 07613153073086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Model Number: 502-01-52E
• Device Catalogue Number: 502-01-52E
• Device Lot Number: 23623501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female