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

Model Number	01.29.209
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs director: about 3 years after primary cementless tha, a dislocation occurs for unreported reasons and, during the attempt at closed reduction, the head is separated from the stem.At this point, closed reduction is no longer possible and a new surgery is required.The manipulation and consequent stresses linked to an attempt of closed reduction is not among the standard activities for an artificial hip joint and it's therefore normal that a disassembly may be caused.No reason to suspect a defective device combination.Visual inspection performed by r&d project manager: from the received parts, no particular signs or defects were noticed in the femoral head and polyethylene liner.The attempts of reduction could have stressed and applied tensile force to the junction head-stem, resulting in the decoupling of the two components.Regarding the femoral head dislocation from the liner that occurred prior, there are no evident signs or defects on the devices; we cannot determine the root cause of the event with the provided information, as multiple variables may have contributed (laxity of tissues, cup position, or particular movements of the leg).Batch reviews performed on 4 august 2025: ball heads: mectacer 01.29.209 mectacer head biolox delta dia.36 12/14-m (k112115) lot 2119467: (b)(4) items manufactured and released on 04/05/2022.Expiration date: 18/04/2027.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.Liner: versafitcup cc trio 01.26.3644hct flat pe hc liner ø36/e lot 2206932 (k120531): (b)(4) items manufactured and released on 11/05/2022.Expiration date: 22/04/2027.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.Stem: amistem p 01.18.406 amistem-p std.Size 6 lot 2115919 (k173794): (b)(4) items manufactured and released on 09/03/2022.Expiration date: 27/02/2027.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 for the initial joint dislocation, 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.The subsequent head-stem dissociation was attributed to the reduction maneuvers performed after the dislocation.Excessive traction or improper technique during hip prosthesis reduction can generate forces exceeding the taper lock between the head and neck, resulting in dissociation.
Event or Problem Description
About 2 years and 11 months after the primary surgery, the patient experienced joint luxation in extension.During reduction attempts performed at the emergency room on (b)(6) 2025, the head dislocated from the stem.Revision surgery was then carried out on (b)(6) 2025.Only liner and head revised (head diameter 32 with sleeve and hooded liner).The surgeon noted that the cup was oversized and that a footplate had formed distally in the femoral diaphysis following the initial implantation.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER HEAD BIOLOX DELTA DIA.36 12/14-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: 22902789
• Report Number: 3005180920-2025-00809
• Device Sequence Number: 8018088
• Product Code: LZO
• UDI-Device Identifier: 07630030809200
• UDI-Public: 07630030809200
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

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: 01.29.209
• Device Lot Number: 2119467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2022
• 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 Age: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White