MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 1236-2-852

Device Problems Degraded (1153); Fracture (1260); Unstable (1667); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Ambulation Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530)

Event Date 07/16/2019

Event Type  Injury  

Event Description

As reported in medwatch: i was in a deep squat and my hip replacement failed and slipped out.I had a bilateral hip replacement with stryker trident psl on 2018.My right hip failed about 3-5 months later cause unknown, right revision on 2019.Left hip failure from a deep squat with the left hip revision surgery on 2022.Additional information reported: patient had a bilateral stryker hip replacement on (b)(6) 2018 with trident product.In (b)(6) 2018, patient noticed instability in right hip.Patient was revised in (b)(6) 2019 due to broken poly liner.Patient mentioned "metal on metal" and alleges high levels of chromium and cobalt.

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.

Manufacturer Narrative

Reported event: an event regarding disassociation and wear involving an adm liner was reported.The event was confirmed via clinician review of provided medical records and evaluation of the provided photograph of the device.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph indicated that there appears to be some minor deformation to the rim of the liner.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry concerns patient who underwent bilateral total hip arthroplasties and then subsequently developed disassociation/dislocation of both of his components.There was also elevation of his chrome and cobalt levels.In my opinion a contributing factor is impingement, especially on the right where a notch is seen on the femoral neck.This can account for not only the mechanical failure but also the elevated ion levels.I can confirm that these events occurred because i was able to review the x-rays and operation reports.Regarding the root cause of failure, i cannot determine this for certain.Causes are multifactorial.Dislocation/disassociation can be caused by surgical technique factors, patient activity and lifestyle factors and less likely implant factors.Elevated ion levels in this case are most likely caused by impingement demonstrated clearly on the right with a notch in the femoral neck." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to articulation of the ceramic head against the metal mdm liner, damage to the polyethylene adm liner, and elevated metal ion levels.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph indicated that there appears to be some minor deformation to the rim of the liner.A review of the provided medical information by a clinical consultant indicated: "this inquiry concerns patient who underwent bilateral total hip arthroplasties and then subsequently developed disassociation/dislocation of both of his components.There was also elevation of his chrome and cobalt levels.In my opinion a contributing factor is impingement, especially on the right where a notch is seen on the femoral neck.This can account for not only the mechanical failure but also the elevated ion levels.I can confirm that these events occurred because i was able to review the x-rays and operation reports.Regarding the root cause of failure, i cannot determine this for certain.Causes are multifactorial.Dislocation/disassociation can be caused by surgical technique factors, patient activity and lifestyle factors and less likely implant factors.Elevated ion levels in this case are most likely caused by impingement demonstrated clearly on the right with a notch in the femoral neck." 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 Description

As reported in medwatch: i was in a deep squat and my hip replacement failed and slipped out.I had a bilateral hip replacement with stryker trident psl on 2018.My right hip failed about 3-5 months later cause unknown, right revision on 2019.Left hip failure from a deep squat with the left hip revision surgery on 2022.Additional information reported: patient had a bilateral stryker hip replacement on (b)(6) 2018 with trident product.In (b)(6) 2018, patient noticed instability in right hip.Patient was revised in (b)(6) 2019 due to broken poly liner.Patient mentioned "metal on metal" and alleges high levels of chromium and cobalt.Update 13/june/2022: as reported in medwatch mw5109954: i was in a deep squat and my hip replacement failed and slipped out.I had a bilateral hip replacement with stryker trident psl on 2018.My right hip failed about 3-5 months later cause unknown, right revision on 2019.Left hip failure from a deep squat with the left hip revision surgery on 2022.Additional information reported via: patient had a bilateral stryker hip replacement on (b)(6) 2018 with trident product.In (b)(6) 2018, patient noticed instability in right hip.Patient was revised in (b)(6) 2019 due to broken poly liner.Patient mentioned "metal on metal" and alleges high levels of chromium and cobalt.Patient noted he has the liner but will consult with an attorney prior to sending to stryker for evaluation.Patient will supply medical records.

Manufacturer Narrative

Reported event: an event regarding disassociation and wear involving an adm liner was reported.The event was confirmed via clinician review of provided medical records and evaluation of the provided photograph of the device.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph indicated that there appears to be some minor deformation to the rim of the liner.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry concerns patient who underwent bilateral total hip arthroplasties and then subsequently developed disassociation/dislocation of both of his components.There was also elevation of his chrome and cobalt levels.In my opinion a contributing factor is impingement, especially on the right where a notch is seen on the femoral neck.This can account for not only the mechanical failure but also the elevated ion levels.I can confirm that these events occurred because i was able to review the x-rays and operation reports.Regarding the root cause of failure, i cannot determine this for certain.Causes are multifactorial.Dislocation/disassociation can be caused by surgical technique factors, patient activity and lifestyle factors and less likely implant factors.Elevated ion levels in this case are most likely caused by impingement demonstrated clearly on the right with a notch in the femoral neck." -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: here have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to articulation of the ceramic head against the metal mdm liner, damage to the polyethylene adm liner, and elevated metal ion levels.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph indicated that there appears to be some minor deformation to the rim of the liner.A review of the provided medical information by a clinical consultant indicated: "this inquiry concerns patient who underwent bilateral total hip arthroplasties and then subsequently developed disassociation/dislocation of both of his components.There was also elevation of his chrome and cobalt levels.In my opinion a contributing factor is impingement, especially on the right where a notch is seen on the femoral neck.This can account for not only the mechanical failure but also the elevated ion levels.I can confirm that these events occurred because i was able to review the x-rays and operation reports.Regarding the root cause of failure, i cannot determine this for certain.Causes are multifactorial.Dislocation/disassociation can be caused by surgical technique factors, patient activity and lifestyle factors and less likely implant factors.Elevated ion levels in this case are most likely caused by impingement demonstrated clearly on the right with a notch in the femoral neck." 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 Description

As reported in medwatch: i was in a deep squat and my hip replacement failed and slipped out.I had a bilateral hip replacement with stryker trident psl on 2018.My right hip failed about 3-5 months later cause unknown, right revision on 2019.Left hip failure from a deep squat with the left hip revision surgery on 2022.Additional information reported: patient had a bilateral stryker hip replacement on (b)(6) 2018 with trident product.In (b)(6) 2018, patient noticed instability in right hip.Patient was revised in (b)(6) 2019 due to broken poly liner.Patient mentioned "metal on metal" and alleges high levels of chromium and cobalt.Update 13/june/2022: as reported in medwatch mw5109954: i was in a deep squat and my hip replacement failed and slipped out.I had a bilateral hip replacement with stryker trident psl on 2018.My right hip failed about 3-5 months later cause unknown, right revision on 2019.Left hip failure from a deep squat with the left hip revision surgery on 2022.Additional information reported via: patient had a bilateral stryker hip replacement on (b)(6) 2018 with trident product.In (b)(6) 2018, patient noticed instability in right hip.Patient was revised in (b)(6) 2019 due to broken poly liner.Patient mentioned "metal on metal" and alleges high levels of chromium and cobalt.Patient noted he has the liner but will consult with an attorney prior to sending to stryker for evaluation.Patient will supply medical records.

• Brand Name: RESTORATION ADM X3 INS 28/52
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14741220
• MDR Text Key: 294586160
• Report Number: 0002249697-2022-00864
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638991
• UDI-Public: 04546540638991
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1236-2-852
• Device Catalogue Number: 1236-2-852
• Device Lot Number: 61056601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 78 KG