MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX OPTION HEADS; HEAD BIOLOX OPTION Ø 28 LOT. 2417354

Model Number	01.29.230H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Implant Pain (4561)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12-dec-2024: lot 2417354: (b)(4) items manufactured and released on 01-07-2024.Expiration date: 2029-06-13.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 item involved in the event, batch review performed on 12-dec-2024: liner: versafitcup dm 01.26.2852mhc double mobility hc liner ø 52/28 (k092265) lot.2409372 lot 2409372: (b)(4) items manufactured and released on 21-05-2024.Expiration date: 2029-05-06.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
One week after primary, the patient came in reporting pain due to a dissociation of the head from the double mobility liner and the cause was unknown.The surgeon revised head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
On (b)(6), we received information that this was a standard dislocation and not an interprostetic one.Devices involved in the complaint batch review performed on (b)(6)2025 liner: mpact dm 01.32.4452cf dm converter tin coated g/dmf (k211891) lot 2310983: (b)(4) items manufactured and released on 08-11-2023.Expiration date: 2028-10-24.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.B5 and h6 updated.The complaint root cause remains unchanged.
Event or Problem Description
Corrected description: one week after primary, the patient came in reporting pain due to a luxation of the double mobility liner from the dm converter (metallic liner).The surgeon revised head, liner and dm converter.Biolox option was used during primary to achieve an xl length while still retaining the wear characteristics of a ceramic head for a size 28mm diameter.The cause of the dislocation is unknown.The surgery was completed successfully.The patient came back on the (b)(6) with signs of an infection, (b)(4) was filed.

• Brand Name: MECTACER BIOLOX OPTION HEADS
• Common Device Name: HEAD BIOLOX OPTION Ø 28 LOT. 2417354
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; CH 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: 21033632
• Report Number: 3005180920-2024-01131
• Device Sequence Number: 4223234
• Product Code: LZO
• UDI-Device Identifier: 07630030809323
• UDI-Public: 07630030809323
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131518
• 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,Followup
• Report Date (Section B): 02/03/2025

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: 01.29.230H
• Device Lot Number: 2417354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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: 78 YR
• Patient Sex: Male