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

Catalog Number	01.29.232H
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2019.On (b)(6) 2021, the patient came in reporting pain due to a dislocation of the head from the liner and the cause of the dislocation is unknown.The surgeon revised the head and liner and the surgery was completed successfully.On the (b)(6) 2024 (2 years and 10 months post primary) the patient had pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised the head, cup and liner.The surgery was completed successfully.The primary surgeon uses a posterior approach.The revision surgeon mentioned that the cup appeared to have too much anteversion.
Additional Manufacturer Narrative
Batch review performed on 30 august 2024.Lot 1909017: (b)(4) items manufactured and released on 12-feb-2020.Expiration date: 2025-02-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional implants revised.Batch review performed on 30 august 2024 on cup: mpact 01.32.154sh acetabular shell ø54 no-hole (k132879) lot.1902286.Lot 1902286: (b)(4) items manufactured and released on 02-jul-2019.Expiration date: 2024-06-22.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 30 august 2024 on liner: mpact 01.32.3644hc10a face-changing 10° pe hc liner ø36/e (k183582) lot.2009675.Lot 2009675: (b)(4) items manufactured and released on 01-dec-2020.Expiration date: 2025-11-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with other 2 cases reported event during the period of review.

• Brand Name: BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 36
• Common Device Name: HIP CERAMIC BALL HEAD
• 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: 20244170
• Report Number: 3005180920-2024-00759
• Device Sequence Number: 15295067
• Product Code: LZO
• UDI-Device Identifier: 07630030809347
• UDI-Public: 07630030809347
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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: 02/02/2025
• Device Catalogue Number: 01.29.232H
• Device Lot Number: 1909017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2020
• 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 Age: 68 YR
• Patient Sex: Female