MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0435
Medical Device Problem Codes	Material Erosion (1214); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported: "a case of metallosis on a patient whose hip prosthesis was implanted.Nickel allergy.".
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.Device not returned.
Event or Problem Description
It was reported: "a case of metallosis on a patient whose hip prosthesis was implanted.Nickel allergy.".
Additional Manufacturer Narrative
Reported event: an event regarding fretting/metallosis and allergy/reaction 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: "as described above, this inquiry concerns a report that a patient who had a nickel allergy, had a total hip replacement, and supposedly developed metallosis.There is a reference to a paper although we don't know where was published nor do we know who the author was, that cites a case report of an accolade tmzf which developed trunnionosis and mechanical failure nine years after implantation.This is unrelated to the implant referred to in the grids.I am unclear as to what the event is.It seems that the event is a patient who developed metallosis.The patient also had a nickel allergy.I cannot confirm that this event occurred since i have no corroborating documentation such as x-rays, office notes, or a revision operation report.The root cause of metallosis/trunnionosis is multifactorial including surgical technique factors, patient bmi and activity factors and 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 it was reported the "dr.Found a case of metallosis on a patient whose hip prosthesis was implanted with a reported nickel allergy.A review of the provided medical information by a clinical consultant indicated: "as described above, this inquiry concerns a report that a patient who had a nickel allergy, had a total hip replacement, and supposedly developed metallosis.There is a reference to a paper although we don't know where was published nor do we know who the author was, that cites a case report of an accolade tmzf which developed trunnionosis and mechanical failure nine years after implantation.This is unrelated to the implant referred to in the grids.I am unclear as to what the event is.It seems that the event is a patient who developed metallosis.The patient also had a nickel allergy.I cannot confirm that this event occurred since i have no corroborating documentation such as x-rays, office notes, or a revision operation report.The root cause of metallosis/trunnionosis is multifactorial including surgical technique factors, patient bmi and activity factors and implant factors." additionally as per the drawing, the composition of this device contains nitrogen, carbon, hydrogen, iron, oxygen, aluminum, vanadium and titanium therefore, could not have contributed to the patients allergic reaction to nickel.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIZE 4 ACCOLADE II 132 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15266933
• Report Number: 0002249697-2022-01207
• Device Sequence Number: 17791993
• Product Code: LPH
• UDI-Device Identifier: 04546540664471
• UDI-Public: 04546540664471
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: 11/30/2021
• Device Model Number: 6720-0435
• Device Catalogue Number: 6720-0435
• Device Lot Number: 57382508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2016
• 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; Other
• Patient Age: 76 YR
• Patient Sex: Female