MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH TIBIAL B/PLT KEEL MED 2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813112
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Osteolysis (2377); Ambulation or Postural Difficulties (2544)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
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.H3 other text : device not returned.
Event or Problem Description
Revision of distal femoral gmrs with mrh tibia.Diagnosis for revision was lysis and suspected femoral stem loosening.Intra-op, the surgeon commented that the tibial construct was loose and also needed to be removed.When removing the tibial construct, the surgeon commented that the stem was not tight on the baseplate and was freely moving (unthreading).Issue noticed after primary procedure, prior to revision procedure.
Event or Problem Description
Revision of distal femoral gmrs with mrh tibia.Diagnosis for revision was lysis and suspected femoral stem loosening.Intra-op, the surgeon commented that the tibial construct was loose and also needed to be removed.When removing the tibial construct, the surgeon commented that the stem was not tight on the baseplate and was freely moving (unthreading).Issue noticed after primary procedure, prior to revision procedure.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and osteolysis involving mrh baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: explantation damage is observed on the surfaces of the devices.There is bone cement on the distal surface of the tray along with bone in-growth on the stem as well.Dimensional inspection: not performed as this event does not relate to a dimensional issue functional inspection: not performed as this event does not relate to a functional issue.Material analysis: material analysis not performed as there was no material integrity issue with this component.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: the x-rays confirm the presence of a cemented distal femoral replacing tka.On the x-rays reviewed the implants are in anatomic position without evidence of loosening or mechanical complication.No osteolysis is evident.I cannot confirm revision tka surgery, component loss of fixation and disassembly from the information provided.Should further documentation become available i would be happy to further this investigation.Device 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 reported lot.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: the x-rays confirm the presence of a cemented distal femoral replacing tka.On the x-rays reviewed the implants are in anatomic position without evidence of loosening or mechanical complication.No osteolysis is evident.I cannot confirm revision tka surgery, component loss of fixation and disassemby from the information provided.The exact cause of the event could not be determined because insufficient information was provided.Additional information are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.

• Brand Name: MRH TIBIAL B/PLT KEEL MED 2
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 18921740
• Report Number: 0002249697-2024-00435
• Device Sequence Number: 17745141
• Product Code: KRO
• UDI-Device Identifier: 07613327045321
• UDI-Public: 07613327045321
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: 07/30/2026
• Device Catalogue Number: 64813112
• Device Lot Number: NH67S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• 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: 64 YR
• Patient Sex: Female