MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4

Model Number	01.29.206
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to an undersized stem.Hip instability was also present.Neither loosening or subsidence were reported.The cause of the undersized stem is unknown.At about 6 months post primary the surgeon revised the head from l to an xl one and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2024: lot (b)(6): (b)(4) items manufactured and released on (b)(6) 2023.Expiration date: 2028-04-16.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.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4
• 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: 21101922
• Report Number: 3005180920-2024-01156
• Device Sequence Number: 8665196
• Product Code: LZO
• UDI-Device Identifier: 07630030809170
• UDI-Public: 07630030809170
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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 Model Number: 01.29.206
• Device Lot Number: 2008026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female