MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 28/-4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	6570-0-028
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via the contact us email form: in (b)(6) 2018 i had bilateral total hip replacement with the stryker trident psl.In approximately (b)(6) 2018 i started experiencing symptoms in my right hip.At the end of (b)(6) x-rays confirmed mechanical failure of the right hip joint.I am scheduled for revision surgery on (b)(6).I am aware of past stryker hip recalls.Was this product recalled? do you have a claims process related to the type of product liability? update (b)(6) 2022 wg: 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: 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.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Additional Manufacturer Narrative
An event regarding disassociation involving a ceramic head 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 gray discoloration along the outer surface of the ceramic head consistent with material transfer from contact with the mdm 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 gray discoloration along the outer surface of the ceramic head consistent with material transfer from contact with the mdm 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 or Problem Description
As reported via the contact us email form: in (b)(6) 2018 i had bilateral total hip replacement with the stryker trident psl.In approximately (b)(6) 2018 i started experiencing symptoms in my right hip.At the end of june x-rays confirmed mechanical failure of the right hip joint.I am scheduled for revision surgery on 8/7.I am aware of past stryker hip recalls.Was this product recalled? do you have a claims process related to the type of product liability? update 13/june/2022 wg: 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: 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.
Event or Problem Description
As reported via the contact us email form: in (b)(6) 2018 i had bilateral total hip replacement with the stryker trident psl.In approximately november 2018 i started experiencing symptoms in my right hip.At the end of june x-rays confirmed mechanical failure of the right hip joint.I am scheduled for revision surgery on 8/7.I am aware of past stryker hip recalls.Was this product recalled? do you have a claims process related to the type of product liability? update 13/june/2022 wg: 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: 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 august 2019 due to broken poly liner.Patient mentioned "metal on metal" and alleges high levels of chromium and cobalt.
Additional Manufacturer Narrative
An event regarding disassociation involving a ceramic head 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 gray discoloration along the outer surface of the ceramic head consistent with material transfer from contact with the mdm 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: there 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 gray discoloration along the outer surface of the ceramic head consistent with material transfer from contact with the mdm 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.

• Brand Name: DELTA V-40 CERAMIC HEAD 28/-4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14952193
• Report Number: 0002249697-2022-00985
• Device Sequence Number: 5586458
• Product Code: LZO
• UDI-Device Identifier: 04546540608468
• UDI-Public: 04546540608468
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2023

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: 01/31/2023
• Device Model Number: 6570-0-028
• Device Catalogue Number: 6570-0-028
• Device Lot Number: 63250005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 08/26/2022; 02/14/2023
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 09/20/2022; 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 78 KG