MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION EXTENSION STEM - CEMENTED Ø 13 L 105; KNEE CEMENTED EXTENSION STEM

Catalog Number	02.07.FSC13105
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 november 2019: lot 1904808: 15 items manufactured and released on 11-sept-2019.Expiration date: 2024-08-31.No anomalies found related to the problem.To date, 1 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medial affairs director.Intraoperative tibial fracture occurred during final implant impaction.Intraoperative fractures are known possible adverse events of total knee replacements and they mainly depend on bone morphology and mechanical properties.In this case, no information concerning patient general health status and previous bone conditions is available.No reason to suspect a faulty device was responsible for the event.
Event or Problem Description
During tibial/stem assembly impaction the tibia bone partially fractured distally.The surgeon treated it discharging the patient load for 45 days.

• Brand Name: GMK-REVISION EXTENSION STEM - CEMENTED Ø 13 L 105
• Common Device Name: KNEE CEMENTED EXTENSION STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9436907
• Report Number: 3005180920-2019-01049
• Device Sequence Number: 16964644
• Product Code: JWH
• UDI-Device Identifier: 07630030823176
• UDI-Public: 07630030823176
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K120790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2019

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: 08/31/2024
• Device Catalogue Number: 02.07.FSC13105
• Device Lot Number: 1904808
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 88