MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; MECTACER MECTACER HEAD BIOLOX DELTA DIA.28 12/14-S

Model Number	01.29.201
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12-may-2025: lot 146022: (b)(4) items manufactured and released on 15-12-2014.Expiration date: 2019-10-31.No anomalies found related to the problem.To date, all items of the same lot have been sold (1 as 1460222a 2 as 146022b) with no similar reported event during the period of review.Additional device involved batch review performed on 12-may-2025: versafitcup 01.26.56mb versafitcup metalback dm ø56 mm (k083116) lot 146518: (b)(4) items manufactured and released on 08-01-2015.Expiration date: 2019-11-30.No anomalies found related to the problem.To date, all items of the same lot have been sold (1 as 146518a) with no similar reported event during the period of review.Versafitcup dm 01.26.2856mhc double mobility hc liner ø28/dmh (k092265) lot 147167: (b)(4) items manufactured and released on 03-12-2014.Expiration date: 2019-10-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 10 years and 3 months from primary, the patient came in reporting pain.The surgeon revised the dm cup/liner to a competitor cup/liner and revised the medacta head with a medacta head.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER MECTACER HEAD BIOLOX DELTA DIA.28 12/14-S
• 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: 22084240
• Report Number: 3005180920-2025-00490
• Device Sequence Number: 15420375
• 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: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2025

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 Expiration Date: 10/31/2019
• Device Model Number: 01.29.201
• Device Lot Number: 146022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2014
• 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: Unknown