MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-0335
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	09/01/2022
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.Not available.
Event or Problem Description
Stem fracture (accolade i) 14 years after implantation and regular function.A revision surgery due to the shaft fracture is now planned.A complex revision surgery must be performed here.Surgery date september 6, after surgery defect item can be returned.Update: the prosthesis neck is not broken.The head has loosened and badly damaged the cone.
Additional Manufacturer Narrative
Reported event.An event regarding disassociation involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was confirmed the event was conformed via clinician review of the provided medical records/ evaluation of the returned deice.Method & results; -product evaluation and results: visual inspection of the returned devices indicated that the trunnion of the stem is severely worn.The metal head appears to have damage from the disassociation event and explantation.Material evaluation was completed and indicated the following comments: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa.No further material analyses were performed.-clinician review: a review of the provided medical records by a clinical consultant indicated: this patient underwent a right primary total hip arthroplasty using an accolade i tmzf hip stem.A v40 cobalt chrome lfit femoral head was utilized with a 36 mm diameter and a zero offset.No clinical history is given.The patient sustained a femoral head disassociation.I can confirm that this event took place since i was able to see x-rays of the primary hip and x-rays of the failed hip arthroplasty.I cannot confirm that the revision took place since i have no documentation such as office notes, post revision x-rays or operation note.Regarding root cause of this event, it cannot be determined with certainty.Causes of femoral head disassociation are multifactorial.The summary describes no fracture of the femoral component but rather findings which could be consistent with trunnionosis and deformity of the trunnion leading to disassociation.Causes could be related to surgical technique, patient bmi and activity level and implant factors as well.In order to assign causality to the implant itself, one would have to have the implant examined by stryker engineers to determine the mechanism of failure.-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 patient underwent a right primary total hip arthroplasty using an accolade i tmzf hip stem.A v40 cobalt chrome lfit femoral head was utilized with a 36 mm diameter and a zero offset.No clinical history is given.The patient sustained a femoral head disassociation.I can confirm that this event took place since i was able to see x-rays of the primary hip and x-rays of the failed hip arthroplasty.I cannot confirm that the revision took place since i have no documentation such as office notes, post revision x-rays or operation note.Regarding root cause of this event, it cannot be determined with certainty.Causes of femoral head disassociation are multifactorial.The summary describes no fracture of the femoral component but rather findings which could be consistent with trunnionosis and deformity of the trunnion leading to disassociation.Causes could be related to surgical technique, patient bmi and activity level and implant factors as well.In order to assign causality to the implant itself, one would have to have the implant examined by stryker engineers to determine the mechanism of failure.Visual inspection of the returned devices indicated that the trunnion of the stem is severely worn.The metal head appears to have minor damage from the disassociation event and explantation.Material evaluation was completed and indicated the following comments: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa 1693894.No further material analyses were performed.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.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
Stem fracture (accolade i) 14 years after implantation and regular function.A revision surgery due to the shaft fracture is now planned.A complex revision surgery must be performed here.Surgery date september 6, after surgery defect item can be returned.Update: the prosthesis neck is not broken.The head has loosened and badly damaged the cone.As per med review: the patient sustained a femoral head disassociation.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #3
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15487415
• Report Number: 0002249697-2022-01403
• Device Sequence Number: 1885755
• Product Code: LPH
• UDI-Device Identifier: 04546540510686
• UDI-Public: 04546540510686
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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: 10/31/2013
• Device Model Number: 6021-0335
• Device Catalogue Number: 6021-0335
• Device Lot Number: 28141503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2008
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 120 KG