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

Model Number	6260-9-332
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
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
Revision surgery.Update 22 january 2021: the surgeon reported that the revision was due to: trochanteric syndrome and trunnionosis.The patient felt pain.Head and liner explanted.Sleeve and biolox head implanted on damaged trunnion.Changed the liner to a 10 degree lip liner, and not proceeding to explant the well fixed femoral component.
Event or Problem Description
Revision surgery update (b)(6) 2021: the surgeon reported that the revision was due to: trochanteric syndrome and trunnionosis.The patient felt pain.Head and liner explanted.Sleeve and biolox head implanted on damaged trunnion.Changed the liner to a 10 degree lip liner, and not proceeding to explant the well fixed femoral component.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion/trunnionosis involving a metal head was reported.The event was not confirmed.Method & results:  -device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 12 march 2022.This inspection indicated: the head was returned in an undamaged state.The condition of the tapered inner diameter shown is consistent with having been in contact with the stem trunnion, though no evidence damage from slipping of the taper lock, nor evidence of trunnionosis corrosion products were seen.A material analysis has been performed.The report concluded: no fractures or corrosion were found on either the x3 liner or the v40 head.No evidence was found of materials non-conformance nor manufacturing defects.Conclusion of assessment: there were claims of trunnionosis and metallosis.However the extent of these findings was unclear.Additionally, there were no supporting findings of increased metal levels, tissue or synovial fluid metallosis and the intraoperative descriptions were quite limited.Obtaining the patholoy reports, photographs of the trunnion, explants (or lot numbers to rule out associated issues) and/ or radiographs may provide additional information for the assessment. -device history review: all 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 reported lot.  conclusion: an event regarding corrosion/trunnionosis was reported.Visual inspection was performed as part of the material analysis report (mar), dated 12 march 2022.This inspection indicated: the head was returned in an undamaged state.The condition of the tapered inner diameter shown is consistent with having been in contact with the stem trunnion, though no evidence damage from slipping of the taper lock, nor evidence of trunnionosis corrosion products were seen.A material analysis has been performed.The report concluded: no fractures or corrosion were found on either the x3 liner or the v40 head.No evidence was found of materials non-conformance nor manufacturing defects.A review of the provided medical records concluded: there were claims of trunnionosis and metallosis.However the extent of these findings was unclear.Additionally, there were no supporting findings of increased metal levels, tissue or synovial fluid metallosis and the intraoperative descriptions were quite limited.Obtaining the patholoy reports, photographs of the trunnion, explants (or lot numbers to rule out associated issues) and/ or radiographs may provide additional information for the assessment.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: marisol santiago ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11340300
• Report Number: 0002249697-2021-00288
• Device Sequence Number: 823372
• Product Code: JDI
• UDI-Device Identifier: 07613327013122
• UDI-Public: 07613327013122
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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: 05/31/2024
• Device Model Number: 6260-9-332
• Device Catalogue Number: 6260-9-332
• Device Lot Number: 71154906
• 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: 01/22/2021
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2019
• 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: 43 YR
• Patient Sex: Female