MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 8; CEMENTLESS STEM

Model Number	01.39.008
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 april 2021 lot 2004245: (b)(4) items manufactured and released on 21-august-2020.Expiration date: 2025-08-06.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold without any other similar reported event clinical evaluation performed by medical affairs director: intraoperative femoral fracture during primary tha surgery.From the images supplied, the femoral stem may have been oversized, perhaps due to insufficient bone quality that was giving a sense onf instability to the surgeon when fitting the stem.The lengthening of the index hip is probably related to the oversizing too.We see no reason to suspect a defective device in this case.
Event or Problem Description
Spiral femur bone fracture happened during surgery.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 8
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11804822
• Report Number: 3005180920-2021-00371
• Device Sequence Number: 17055586
• Product Code: LZO
• UDI-Device Identifier: 07630030885570
• UDI-Public: 07630030885570
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 08/06/2025
• Device Model Number: 01.39.008
• Device Catalogue Number: 01.39.008
• Device Lot Number: 2004245
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/11/2021
• 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: Required Intervention
• Patient Age: 62 YR