MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY SHELLS; MPACT DM ACETABULAR SHELL Ø54

Model Number	01.32.154MB
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 september 2025.Liner: mpact dm 01.26.2854mhc double mobility hc liner ø28/dmg (k092265) lot.2503761: (b)(4) items manufactured and released on 30-apr-2025.Expiration date: 08-apr-2030.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.Ball heads: inox 25055.2803 316lvm ball head 12/14 ø28 mm size m (not registered in us) lot.2430420: (b)(4) items manufactured and released on 26-mar-2025.Expiration date: 13-mar-2030.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.Cup: mpact 01.32.154mb mpact dm acetabular shell ø54 (k143453) lot.2421851: (b)(4) items manufactured and released on 07-jan-2025.Expiration date: 16-dec-2029.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: one month after tha with a double mobility insert, the patient suffered a dislocation during rehabilitation (traumatic event neither confirmed nor denied) and closed reduction was performed in the emergency room.This led to an unsatisfactory result and further surgery, which confirmed the dislocation of the head from the insert.It is extremely likely that the dissociation occurred during the closed reduction procedure, which subjects the polyethylene insert to very high, unpredictable, and unforeseen stresses and can easily induce a lever mechanism leading to dissociation.Double mobility cups have great resistance to dislocation, but once dislocation occurs, it is also very difficult to reduce the joint into its socket, and this often leads to dissociation between the insert and the head.There is no reason to suspect that a defective device was the cause of this adverse event.
Event or Problem Description
During her stay at the rehabilitation centre (the patient was previously revised due to chronic infection), the patient suffered a joint luxation (dm liner along with head dislocated from the cup) of her prosthesis on (b)(6) 2025, 2 months after the previous surgery.The cause of this dislocation has not been clearly identified.The patient was sent to the emergency department of the nearest hospital.The reduction was performed in the operating theatre under general anaesthesia.According to the surgeon on duty, the reduction was easily performed.However, follow-up x-ray raised doubts about the success of the reduction.Another surgeon was consulted and he concluded that x-rays showed a dissociation between the dm liner and head.An emergency revision was performed on (b)(6) 2025 by the consulted surgeon.After incision, a large haematoma was drained and it was confirmed that the insert had become detached from the head.It was found to be almost subcutaneous.Dm liner and head replaced.It is confirmed that the dissociation between the dm liner and the head happened only after the closed reduction.Regarding the joint dislocation, the surgeon reported that the hematoma may have contributed to the event.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the dual mobility liner was received and inspected: visual inspections revealed that the retentive diameter was slightly overdimensioned and, in particular, with enlarged dimensional values (from ø26.37mm to ø26.49mm instead of values from ø26.10mm to ø26.30mm).From the received information, it is not possible to determine with certainty the root cause of the event, but it's probably related to the first dislocation between dm liner and shell that could have also damaged the connection between liner and head, reducing the retentive resistance of the dm liner.Moreover, the first luxation (the one of the dm liner with respect to the shell) probably occurred during an apparently vertical position of the shell, even if it is not clear from the x-ray images.Anyway, these types of discrepancies will be continuously monitored.Conclusion: the root cause of the joint luxation could not be clearly identified, 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.Regarding the dissociation of the head from the double mobility liner, this occurred during reduction maneuvers.Excessive traction or improper technique during attempts to reduce a dislocated hip prosthesis can generate excessive forces, leading to dissociation.No device design or manufacturing related root cause is suspected.

• Brand Name: MPACT DOUBLE MOBILITY SHELLS
• Common Device Name: MPACT DM ACETABULAR SHELL Ø54
• 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: 23367258
• Report Number: 3005180920-2025-01008
• Device Sequence Number: 9950674
• Product Code: MEH
• UDI-Device Identifier: 07630030860980
• UDI-Public: 07630030860980
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143453
• 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): 12/19/2025

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: 01.32.154MB
• Device Lot Number: 2421851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White