MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; FLAT PE HC LINER Ø 32 / E

Model Number	01.32.3244HCT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After the cup and screws were inserted, the liner was impacted as usual.However, the liner was not fully seated and was positioned 2 mm above its intended location.The screw heads and any possible interposing material were checked, and the liner was impacted again, but it still did not seat completely into the cup.One of the screws was removed and another attempt was made to impact the liner, but it could not be fixed securely.Damage was observed on the liner's tab, so a new liner of the same type but different lot was opened and used.The second liner was impacted without any issues.Delay time is about 20min.
Additional Manufacturer Narrative
Batch review performed on 28 july 2025: liner: mpact 01.32.3244hct flat pe hc liner ø32/e (k103721), lot 2339892: 100 items manufactured and released on 16-nov-2023.Expiration date: 2028-10-31.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 component involved in the event: cup: mpact 3d metal 01.38.052dh mpact 3d metal shell two hole ø52mm (k171966) lot 2505249: (b)(4) items manufactured and released on 21-may-2025.Expiration date: 2030-05-07.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.We are waiting to receive the device back to analyze it.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.
Additional Manufacturer Narrative
Batch review performed on 28 july 2025: liner: mpact 01.32.3244hct flat pe hc liner ø32/e (k103721) lot 2339892: (b)(4) items manufactured and released on 16-nov-2023.Expiration date: 2028-10-31.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 3d metal 01.38.052dh mpact 3d metal shell two hole ø52mm (k171966) lot 2505249: (b)(4) items manufactured and released on 21-may-2025.Expiration date: 2030-05-07.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.Visual inspection performed by medacta hip r&d project manager: the liner appeared slightly damaged, most probably for the several attempts to insert it in the cup.From the visual analysis, except for the damage that occurred during the attempts, no particular signs were noticed that could be related to implant defects; moreover, a functional test was done to impact the liner in a shell of the related size: the liner was properly seated inside, confirming a correct dimensioning and functioning of the device.From the received information, it is not possible to determine the root cause of the event, but it is probably related to the presence of liquid or tissues that could have prevented the complete insertion of the liner.Root cause: it is most likely that the cause of the reported problem was the presence of some remaining liquid or an lack of alignment between the components.The device history record review does not indicate any potentially related manufacturing issue.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: FLAT PE HC LINER Ø 32 / E
• 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: 22727963
• Report Number: 3005180920-2025-00777
• Device Sequence Number: 18384523
• Product Code: LZO
• UDI-Device Identifier: 07630030811913
• UDI-Public: 07630030811913
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01.32.3244HCT
• Device Lot Number: 2339892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian