MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S

Model Number	01.29.208
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 aug 2025.Ball heads: mectacer 01.29.208 mectacer head biolox delta dia.36 12/14-s (k112115) lot: 164977: (b)(4) items manufactured and released on 04-nov-2016.Expiration date: 2021-oct-25.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.Liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot.165917: (b)(4) items manufactured and released on 02-nov-2016.Expiration date: 2021-oct-18.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.Root cause: 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 8 years 5 months from primary, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Correction: b5 updated after new info received on 12 september 2025.Additional info: clinical evaluation performed by clinical affairs director: 8+ years after primary cementless tha, dislocation occurs, and a revision operation is called for.The single radiograph supplied is not dated and gives very little useful information: the dislocation is not visible.If this were the situation just before dislocation, the event comes as a small surprise, because there can hardly be any soft tissue tension in these conditions, so a retentive liner may be called for.According to additional information, the greater trochanter fracture occurred during index surgery due to very poor bone quality - it is very likely that after fracture healing, the total limb length was reduced, and soft tissue tension never recovered, so the final dislocation occurred.
Event or Problem Description
On (b)(6) 2017, the patient had hip arthroplasty primary surgery, and the greater trochanter fracture occurred.Surgeon noted very poor bone quality and a fracture that led him to place two cutclage cables during that procedure.At 8 years 5 months from primary, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised the head and liner.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 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: 23036826
• Report Number: 3005180920-2025-00836
• Device Sequence Number: 9514869
• Product Code: LZO
• UDI-Device Identifier: 07630030809194
• UDI-Public: 07630030809194
• 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: 2017
• 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,Followup
• Report Date (Section B): 10/02/2025

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: 10/25/2021
• Device Model Number: 01.29.208
• Device Lot Number: 164977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2016
• 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: 76 YR
• Patient Sex: Female
• Patient Race: White