MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; FEMORAL HEAD Ø 28 SIZE M

Model Number	01.29.202
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27-05-2025.Lot 2500677: (b)(4) items manufactured and released on 03-02-2025.Expiration date: 2030-01-12.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 components involved and revised: batch review performed on 27-05-2025 liner: versafitcup dm 01.26.2852mhc double mobility hc liner ø28/dmf (k092265) lot 2339844: (b)(4) items manufactured and released on 31-10-2023.Expiration date: 2028-10-11.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.Batch review performed on 27-05-2025 cup: mpact 01.32.162dh acetabular shell ø62 two-holes (k132879) lot 2202245: (b)(4) items manufactured and released on 10-05-2022.Expiration date: 2027-04-22.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.Clinical evaluation performed clinical affairs department.A revision surgery was performed approximately one month after the previous revision, due to a hip dislocation accompanied by dissociation between the femoral head and the dm liner.The available post-operative x-ray image does not reveal any apparent anomalies.The pre-revision x-ray clearly confirm the dislocation.Based on the current information, it is difficult to determine the precise cause of the failure.Specifically, it remains unclear whether the dislocation of the head from the linear led to the liner dissociation from the dm converter or vice-versa.It is worth nothing that a considerable force is typically required to uncouple the femoral head from the dm liner, further complicating the interpretation.At this stage, no definitive conclusions can be drawn.
Event or Problem Description
On the (b)(6) 2025, the patient underwent a hip revision due to femur fracture.Competitor stem was removed, amis-k implanted and contextually medacta dm converter implanted.At about 1 month from previous revision, the patient returned to the hospital reporting a dislocation.After an attempt to close-reduce the dislocation without surgery, the surgeon decided to open the patient and found the head dislocated from the dm liner and the dm liner dislocated from the dm converter.It is possible that the head dislocated from the dm liner during the close-reduction maneuver but this cannot be confirmed.Surgeon revised the head, liner and also the dm converter along with the cup as he was not satisfied with its position.Kerboul cage and vercacem implanted.
Additional Manufacturer Narrative
Visual inspection performed by r&d department.Visual inspection performed on 18 july 2025.From the received pieces, the ball head showed visible dark signs on a side, while the dm liner external surface was quite damaged with several scratches.The retentive diameter of the liner was measured: from a preliminary analysis it resulted slightly enlarged (until 0.1 mm over the maximum tolerance), further dimensional analysis was requested.Dimensional analysis confirmed the slight over-dimension in the retentive diameter (+0.1mm); the reason for the over dimension is likely related to the deformation occured after dislocation of the head, and probably due the subsequent potential sollecitations from the femoral head on the retentive diameter, also is possible that slight deformations occurred during the washing/cleaning and sterilization processes.From the received information, it is not possible to determine with certainty the root cause of the event, but probably the reason of the intra-prosthestic dislocation is related to the attempts of closed reduction.Updated fields: h11.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: FEMORAL HEAD Ø 28 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: 22288958
• Report Number: 3005180920-2025-00555
• Device Sequence Number: 8319629
• Product Code: LZO
• UDI-Device Identifier: 07630030809132
• UDI-Public: 07630030809132
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/28/2025

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: 01.29.202
• Device Lot Number: 2500677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White