MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; FLAT PE HC LINER Ø 36 / F

Model Number	01.32.3648HCT
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 september 2025: lot 188510: (b)(4) items manufactured and released on 27-nov-2018.Expiration date: 2023-11-14.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 by medacta medical affairs manager: 6 years after revision thr, where a medacta cup was used with a competitor stem (presumably the stem that had been implanted at primary surgery), the surgeon notices an eccentric position of the femoral head at a standard follow up radiograph.The eccentricity may be real or apparent and it was not quantified.Additional imaging could supply better evidence of the possibility.No evident signs of osteolysis induced by wear particles, even though the lateral aspect of the femur is very radiotransparent - but it could be natural bone rarefaction.The head may still be the original one used at primary surgery, possibly not even medacta.The possibility of scratches and damages to the head, perhaps during the frst revision operation, cannot be ruled out.As no further revision surgery has been carried out, no further comment can be offered at this stage.Conclusion: 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 investigation does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient had primary hip surgery on (b)(6) 2019 treatment of osteoarthritis.During a follow-up (at about 6 years and 5 months post primary), the surgeon noticed that the head looked eccentric inside the poly, which could possibly indicate polyethylene wear.The patient reports no pain.His activity level is pretty high.He regularly works out and plays tennis.There is no plan for a revision surgery.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: FLAT PE HC LINER Ø 36 / F
• 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: 23289849
• Report Number: 3005180920-2025-01011
• Device Sequence Number: 5470026
• Product Code: LZO
• UDI-Device Identifier: 07630030812132
• UDI-Public: 07630030812132
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 10/14/2025

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: 11/14/2023
• Device Model Number: 01.32.3648HCT
• Device Lot Number: 188510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2018
• 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 Sex: Unknown
• Patient Weight: 85 KG