MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 2 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6721-0230
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Additional 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.Device not returned to the manufacturer.
Event or Problem Description
"trunnionosis stem brace 2 and metal head 32mm +4mm.".
Additional Manufacturer Narrative
Reported event: an event regarding wear/trunnionosis involving an accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: material, dimensional, functional and material analysis could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "unfortunately, there is little documentation for either of these inquiries and no office notes, operation notes or any other documentation was provided.It appears that either one patient had bilateral total hip arthroplasties, or these inquiries may concern two separate patients.I cannot confirm that any of these events occurred since there is no supporting documentation.In addition, the pi reporting is incomplete without documentation.There is mention that trunnionosis was involved in both of these inquiries which led to revision.The causes of trunnionosis are multifactorial including surgical technique factors such as proper assembly and preparation of the implants, as well as implantation, positioning, orientation, and fixation.Patient factors may also be involved including bmi and activity level, as well as implant factors." product history review: a review of the device history records indicates devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: no other similar events were reported for the lot.Conclusions: it was reported that the patient was revised due to trunnionosis.A review of the provided medical records by a clinician indicated the following: "unfortunately, there is little documentation for either of these inquiries and no office notes, operation notes or any other documentation was provided.It appears that either one patient had bilateral total hip arthroplasties, or these inquiries may concern two separate patients.I cannot confirm that any of these events occurred since there is no supporting documentation.In addition, the pi reporting is incomplete without documentation.There is mention that trunnionosis was involved in both of these inquiries which led to revision.The causes of trunnionosis are multifactorial including surgical technique factors such as proper assembly and preparation of the implants, as well as implantation, positioning, orientation, and fixation.Patient factors may also be involved including bmi and activity level, as well as implant factors." 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
"trunnionosis stem brace 2 and metal head 32mm +4mm.".
Additional Manufacturer Narrative
Reported event: an event regarding wear/trunnionosis involving an unknown accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: material, dimensional, functional and material analysis could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "unfortunately, there is little documentation for either of these inquiries and no office notes, operation notes or any other documentation was provided.It appears that either one patient had bilateral total hip arthroplasties, or these inquiries may concern two separate patients.I cannot confirm that any of these events occurred since there is no supporting documentation.In addition, the pi reporting is incomplete without documentation.There is mention that trunnionosis was involved in both of these inquiries which led to revision.The causes of trunnionosis are multifactorial including surgical technique factors such as proper assembly and preparation of the implants, as well as implantation, positioning, orientation, and fixation.Patient factors may also be involved including bmi and activity level, as well as implant factors." 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 trunnionosis.A review of the provided medical records by a clinician indicated the following: "unfortunately, there is little documentation for either of these inquiries and no office notes, operation notes or any other documentation was provided.It appears that either one patient had bilateral total hip arthroplasties, or these inquiries may concern two separate patients.I cannot confirm that any of these events occurred since there is no supporting documentation.In addition, the pi reporting is incomplete without documentation.There is mention that trunnionosis was involved in both of these inquiries which led to revision.The causes of trunnionosis are multifactorial including surgical technique factors such as proper assembly and preparation of the implants, as well as implantation, positioning, orientation, and fixation.Patient factors may also be involved including bmi and activity level, as well as implant factors." the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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
"trunnionosis stem brace 2 and metal head 32mm +4mm.".

• Brand Name: SIZE 2 ACCOLADE II 127 DEG
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 15146207
• Report Number: 0002249697-2022-01132
• Device Sequence Number: 5463882
• Product Code: LPH
• UDI-Device Identifier: 04546540669476
• UDI-Public: 04546540669476
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2022

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: 06/30/2023
• Device Model Number: 6721-0230
• Device Catalogue Number: 6721-0230
• Device Lot Number: 64713603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 10/10/2022; 11/14/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 11/01/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 120 KG