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	Unequal Limb Length (4534)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months after the primary, the patient came in reporting a leg length discrepancy.The surgeon revised the head and liner and added an option sleeve.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 29 july 2024 lot 2402157: (b)(4) manufactured and released on 06-feb-2024.Expiration date: 2029-01-21.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Additional implant revised.Batch review performed on 29 july 2024 on liner: versafitcup dm 01.26.2854mhc double mobility hc liner ø 54/28 (k092265) lot.2305340 lot 2305340: (b)(4) manufactured and released on 07-june-2023.Expiration date: 2028-05-28.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.

• 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: 19936769
• Report Number: 3005180920-2024-00641
• Device Sequence Number: 14675140
• Product Code: LZO
• UDI-Device Identifier: 07630030809125
• UDI-Public: 07630030809125
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 08/08/2024

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: 2402157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• 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: 66 YR
• Patient Sex: Male