MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S - 3.5; HIP CERAMIC BALL HEAD

Catalog Number	01.29.201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 january 2024.Lot 2113855: (b)(4) manufactured and released on 20-dec-2021.Expiration date: 2026-dec-05.No anomalies found related to the problem.To date, 91 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 1 year and 4 months from the primary, the patient came in reporting pain and the cause was unknown.During the revision surgery, a bone tamp was used to remove the head and the dm liner from the trunion.After hitting once with mallet, the ceramic head broke into multiple pieces within the dm liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 05 january 2024.Lot 2113855: (b)(4) items manufactured and released on 20-dec-2021.Expiration date: 2026-dec-05.No anomalies found related to the problem.To date, 91 items of the same lot have been sold with no similar reported event during the period of review.Other device involved: batch review performed on 01 march 2024.Liner: versafitcup dm 01.26.2850mhc double mobility hc liner ø 50/28 (k092265) lot 2000167: (b)(4)items manufactured and released on 16-apr-2020.Expiration date: 2025-march-31.No anomalies found related to the problem.To date, 141 items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by r&d project manager from the received pieces, it was not possible to determine with certainty the root cause of the event; the ball head was broken in two parts, but without any particular sign of failure related to the pain, while the dm liner did not show particular signs too, except for some scratches most probably occurred for the revision and the friction with the pieces of the broken head, also broken during removal.

• Brand Name: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S - 3.5
• 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: 18585791
• Report Number: 3005180920-2024-00002
• Device Sequence Number: 18265571
• Product Code: LZO
• UDI-Device Identifier: 07630030809125
• UDI-Public: 07630030809125
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 03/28/2024

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 Catalogue Number: 01.29.201
• Device Lot Number: 2113855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2021
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 95 KG