MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-5-132
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
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 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.
Event or Problem 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.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion and abnormal ion level involving a metal head was reported.Corrosion and abnormal ion level was confirmed via evaluation of the returned device and clinician review of the provided medical records.Method & results: product evaluation and results: visual inspection: damage was observed on the head taper.This damage was consistent with the interaction between the head taper and stem trunnion.Debris was observed on the articulating surface and taper of the head.Eds showed the head base alloy was consistent with astm f1537 alloy and the samples of debris were consistent with a corrosion product, an oxide, material transfer from a stem base alloy and biological material.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.Visual inspection of the returned device indicated that damage was observed on the head taper.This damage was consistent with the interaction between the head taper and stem trunnion.Debris was observed on the articulating surface and taper of the head.Eds showed the head base alloy was consistent with astm f1537 alloy and the samples of debris were consistent with a corrosion product, an oxide, material transfer from a stem base alloy and biological material.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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion and abnormal ion level involving a metal head was reported.Corrosion was confirmed via evaluation of the returned device.Abnormal ion level was not confirmed.Method & results: product evaluation and results: visual inspection: damage was observed on the head taper.This damage was consistent with the interaction between the head taper and stem trunnion.Debris was observed on the articulating surface and taper of the head.Eds showed the head base alloy was consistent with astm f1537 alloy and the samples of debris were consistent with a corrosion product, an oxide, material transfer from a stem base alloy and biological material.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 the 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.Visual inspection of the returned device indicated that damage was observed on the head taper.This damage was consistent with the interaction between the head taper and stem trunnion.Debris was observed on the articulating surface and taper of the head.Eds showed the head base alloy was consistent with astm f1537 alloy and the samples of debris were consistent with a corrosion product, an oxide, material transfer from a stem base alloy and biological material.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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem 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: 32MM STD V40 TAPER VIT HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 15621358
• Report Number: 0002249697-2022-01502
• Device Sequence Number: 6385855
• Product Code: JDI
• UDI-Device Identifier: 07613327012873
• UDI-Public: 07613327012873
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 6260-5-132
• Device Catalogue Number: 6260-5-132
• Device Lot Number: 61501302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 02/15/2023; 12/15/2023
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 03/09/2023; 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2017
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 54 KG