MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; FEMORAL HEAD Ø 32 SIZE M

Model Number	01.29.205
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 aug 2025 ball heads: mectacer 01.29.205 mectacer head biolox delta dia.32 12/14-m (k112115) lot 2114364: 150 items manufactured and released on 10-jan-2022.Expiration date: 2026-12-22.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 component involved and revised: batch review performed on 04 aug 2025 cup: versafitcup 01.32.148dh acetabular shell ø48 two-holes (k230011) lot 2115585: (b)(4) items manufactured and released on 24-jan-2022.Expiration date: 2027-01-10.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.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At 3 years 2 months from primary, the patient came in due to instability with unknown cause.The surgeon upsized the head.Additionally, the surgeon believed the cup was loose, so he revised the cup and liner with competitor devices.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: FEMORAL HEAD Ø 32 SIZE M
• 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: 22792530
• Report Number: 3005180920-2025-00791
• Device Sequence Number: 18345148
• Product Code: LZO
• UDI-Device Identifier: 07630030809163
• UDI-Public: 07630030809163
• 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: 2025
• 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): 08/13/2025

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: 01/10/2022
• Device Model Number: 01.29.205
• Device Lot Number: 2114364
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2022
• 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 Sex: Female