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

Catalog Number 64813112

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 02/20/2024

Event Type  Injury  

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 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.

• Brand Name: MRH TIBIAL B/PLT KEEL MED 2
• Type of Device: 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
• MDR Text Key: 337873910
• Report Number: 0002249697-2024-00435
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045321
• UDI-Public: 07613327045321
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K002552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 64813112
• Device Lot Number: NH67S
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/09/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female