MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNI ADAPTOR SLEEVE V40 TI; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6519-T-100

Device Problems Material Erosion (1214); Device Appears to Trigger Rejection (1524)

Patient Problems Foreign Body Reaction (1868); Metal Related Pathology (4530)

Event Date 07/26/2022

Event Type  Injury  

Event Description

It was reported: "a case of metallosis on a patient whose hip prosthesis was implanted.Nickel allergy.".

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.

Manufacturer Narrative

Reported event: an event regarding fretting/metallosis and allergy/reaction involving an other hip sleeve 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.

Event Description

It was reported: "a case of metallosis on a patient whose hip prosthesis was implanted.Nickel allergy.".

• Brand Name: UNI ADAPTOR SLEEVE V40 TI
• Type of Device: 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15266959
• MDR Text Key: 298323085
• Report Number: 0002249697-2022-01208
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 04546540608390
• UDI-Public: 04546540608390
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 6519-T-100
• Device Catalogue Number: 6519-T-100
• Device Lot Number: 60845501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2017
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female