MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-332
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	05/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had effusion and fluid buildup.Patient had a washout and debridement of their implants.The liner and head were revised.Right hip.Update per medical review: "a procedure was undertaken on (b)(6) 2020.There was evidence of trunnionosis.No statements of metal debris were noted.In the patient letter it was stated that the surgery found metallosis and trunnionosis.".
Additional Manufacturer Narrative
An event regarding corrosion/ trunnionosis involving a metal head was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: the device is returned in a used condition.A material analysis has been performed.The report concluded: areas of the femoral head taper previously in contact with the accolade ii stem¿s trunnion feature contained dark adhered debris and surface texture variations consistent with a mechanically assisted corrosion process.The debris composition was consistent with corrosion products from being implanted.No evidence was found indicating a material non-conformance nor any manufacturing defects deviating from the design.Clinician review: a review of the provided medical records by a clinical consultant indicated: adverse event identified: revision surgeries for "trunnionosis".Hazards: there were multiple claims of trunnionosis which could present a hazard relative to implant.However, the extent of finding was unclear.Additionally, there were no supporting findings of increased metal levels, tissue or synovial fluid metallosis.Obtaining the pathology reports, photographs of trunnion, explants (or lot numbers to rule out associated issues) and/or radiographs may provide additional information for the assessment.Conclusion of assessment: there were claims of trunnionosis and metallosis.However, the extent of these findings was unclear.Additionally, there were no supporting findings increased metal levels, tissue or synovial fluid metalosis and the intraoperative descriptions were quite limited.Obtaining the pathology reports, photographs of the trunnion, explants (or lot numbers to rule out associated issues) and/or radiography may provide additional information for the assessment.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 had effusion and fluid buildup with evidence of trunnionosis and metallosis.Patient had a washout and debridement performed with liner and head revised.The device is returned in a used condition.The material analysis concluded that areas of the femoral head taper previously in contact with the accolade ii stem's trunnion feature contained dark adhered debris and surface texture variations consistent with a mechanically assisted corrosion process.The debris composition was consistent with corrosion products from being implanted.No evidence was found indicating a material non-conformance nor any manufacturing defects deviating from the design.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports and pre- and post-operative x-rays are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 32MM +8 LFIT V40 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14219048
• Report Number: 0002249697-2022-00621
• Device Sequence Number: 5389343
• Product Code: JDI
• UDI-Device Identifier: 07613327013122
• UDI-Public: 07613327013122
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

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: 06/20/2022
• Device Model Number: 6260-9-332
• Device Catalogue Number: 6260-9-332
• Device Lot Number: 59461305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 66 KG