MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6; CEMENTLESS STEM

Model Number 01.39.206

Device Problem Output Problem (3005)

Patient Problem Loss of Range of Motion (2032)

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on 23 september 2021: lot 2007287: (b)(4) items manufactured and released on 20-oct-2020.Expiration date: 2025-10-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Additional item involved in the event, batch review performed on 23 september 2021.Ball heads: mectacer 01.29.212 biolox delta ceramic ball head 12/14 ø 40 size s - 4 (k112115) lot.1909764.Lot 1909764: (b)(4) items manufactured and released on 3-mar-2020.Expiration date: 2025-02-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.

Event Description

3 days after the primary surgery the patient came in reporting tightness in the hip and the cause of the tightness is unknown.The surgeon revised the stem (from size 6 to size 5) and head (from size s to size l) and the surgery was completed successfully.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6
• Type of Device: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12623812
• MDR Text Key: 276156023
• Report Number: 3005180920-2021-00797
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030885662
• UDI-Public: 07630030885662
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/13/2021

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
• Device Operator: Health Professional
• Device Model Number: 01.39.206
• Device Catalogue Number: 01.39.206
• Device Lot Number: 2007287
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2020
• 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): Required Intervention