MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; MECTACER MECTACER HEAD BIOLOX DELTA DIA.32 12/14-L

Model Number	01.29.206
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On the (b)(6) 2024 the patient underwent hip surgery.On the (b)(6) 2024 the surgeon revised the head due to dislocation of the head from the liner.On, (b)(6) 2025 the patient came in reporting instability and dislocation.The surgeon revised cup, head and liner.Surgery was completed successfully using a double mobility option.
Additional Manufacturer Narrative
Batch review performed on 31-march-2025: lot 2416427: (b)(4) items manufactured and released on 21-06-2024.Expiration date: 2029-06-05.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 devices involved: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot 2342333: (b)(4) items manufactured and released on 06-12-2023.Expiration date: 2028-11-05.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.Mpact 3d metal 01.38.050dh mpact 3d metal shell two hole ø50mm (k171966) lot 2401174: (b)(4) items manufactured and released on 13-02-2024.Expiration date: 2029-01-29.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.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER MECTACER HEAD BIOLOX DELTA DIA.32 12/14-L
• 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: 21855296
• Report Number: 3005180920-2025-00311
• Device Sequence Number: 20004688
• Product Code: LZO
• UDI-Device Identifier: 07630030809170
• UDI-Public: 07630030809170
• 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: 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): 04/17/2025

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: 2416427
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• 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