MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 1 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6721-0127

Device Problem Corroded (1131)

Patient Problem Metal Related Pathology (4530)

Event Date 09/21/2022

Event Type  Injury  

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.

Event Description

It was reported that following detection of a high level of ions metal in patient blood with lump it was discovered there was trunnionosis on the accolade 2 with 32mm metal head.Revision case: removed femoral head, implanted titanium sleeve +4mm with universal biolox 32mm head.Black corrosion was visible on accolade 2 trunnion and inside the 32mm metal head.

Manufacturer Narrative

Reported event: an event regarding corrosion/trunnionosis and abnormal ion level involving an accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections 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: 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 high metal ions and trunnionosis/corrosion at the stem-head interface.A review of the provided medical information by a clinical consultant indicated that insufficient information was provided to confirm the reported events and/or determine root cause.Further information such as pathology reports, additional pre- and post-operative x-rays 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that following detection of a high level of ions metal in patient blood with lump it was discovered there was trunnionosis on the accolade 2 with 32mm metal head.Revision case: removed femoral head, implanted titanium sleeve +4mm with universal biolox 32mm head.Black corrosion was visible on accolade 2 trunnion and inside the 32mm metal head.

Manufacturer Narrative

Reported event: an event regarding corrosion/trunnionosis and abnormal ion level involving an accolade stem was reported.The event was confirmed via 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 remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this product inquiry concerns a patient who underwent sequential bilateral total hip arthroplasties with an accolade stem and a metal head.The patient developed elevated metal ion levels bilaterally that required revision surgery.I can confirm that the patient had primary and revision surgeries of both hips, since i was able to review the operation reports of the revision surgery on each hip.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: 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 high metal ions and trunnionosis/corrosion at the stem-head interface.A review of the provided medical information by a clinical consultant indicated: "this product inquiry concerns a patient who underwent sequential bilateral total hip arthroplasties with an accolade stem and a metal head.The patient developed elevated metal ion levels bilaterally that required revision surgery.I can confirm that the patient had primary and revision surgeries of both hips, since i was able to review the operation reports of the revision surgery on each hip.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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that following detection of a high level of ions metal in patient blood with lump it was discovered there was trunnionosis on the accolade 2 with 32mm metal head.Revision case: removed femoral head, implanted titanium sleeve +4mm with universal biolox 32mm head.Black corrosion was visible on accolade 2 trunnion and inside the 32mm metal head.

• Brand Name: SIZE 1 ACCOLADE II 127 DEG
• 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; centennial park, elstree; limerick WD6 3-SJ ; EI WD6 3SJ ; 61498200
• MDR Report Key: 15623961
• MDR Text Key: 301913095
• Report Number: 0002249697-2022-01508
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540669469
• UDI-Public: 04546540669469
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup,Followup
• Report Date: 01/08/2024

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: 07/31/2022
• Device Model Number: 6721-0127
• Device Catalogue Number: 6721-0127
• Device Lot Number: 60226203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 12/16/2022; 12/15/2023
• Supplement Dates FDA Received: 01/10/2023; 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2017
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 54 KG