MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION Ø 36; HIP MECTACER HEAD BIOLOX

Model Number	01.29.232H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a right primary hip surgery on (b)(6) 2022 and a left primary hip surgery on (b)(6)2022.On (b)(6) 2022, the patient came in reporting instability in both hips and the surgeon revised the head and liner on both the right and left sides.Presently, on (b)(6)2023, the surgeon determined that the patient was over-lengthened in both hips.The surgeon revised the head, sleeve, and liner on both sides of the hip and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 26-apr-2023.Lot 19c0066: (b)(4) items manufactured and released on 11-dec-2019.Expiration date: 2024-12-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Other devices involve: ball heads: mectacer 01.29.232h head biolox option ø 36 (k131518) lot 2113578: (b)(4) items manufactured and released on 12-jan-2022.Expiration date: 2027-01-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Ball heads: mectacer 01.29.242a sleeve size l (k131518) lot 1907393: (b)(4) items manufactured and released on 27-nov-2019.Expiration date: 2024-11-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Ball heads: mectacer 01.29.243a sleeve size xl (k131518) lot 19c0075: (b)(4) items manufactured and released on 11-dec-2019.Expiration date: 2024-11-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Liner: mpact 01.32.3641hc4 offset 4mm pe hc liner ø36/d (k183582) lot 2111831: (b)(4) items manufactured and released on 09-nov-2021.Expiration date: 2026-10-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.

• Brand Name: BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION Ø 36
• Common Device Name: HIP MECTACER HEAD BIOLOX
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16813414
• Report Number: 3005180920-2023-00309
• Device Sequence Number: 5733823
• Product Code: LZO
• UDI-Device Identifier: 07630030809347
• UDI-Public: 07630030809347
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2023

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: 12/01/2024
• Device Model Number: 01.29.232H
• Device Catalogue Number: 01.29.232H
• Device Lot Number: 19C0066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2019
• 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: Required Intervention
• Patient Sex: Female