MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DM DM CONVERTER TIN COATED F/DME; MPACT LINER, CONVERTER TO DOUBLE MOBILITY

Catalog Number	01.32.4248CF
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07-jun-2024: lot 2317571: (b)(4) items manufactured and released on 14-nov-2023.Expiration date: 2028-10-25.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 devices involved batch review performed on 07-jun-2024: liner: mpact dm 01.26.2850mhc double mobility hc liner 28/dme (k092265) lot 2346560: (b)(4) items manufactured and released on 22-jan-2024.Expiration date: 2029-01-08.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: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot 2406490: (b)(4) items manufactured and released on 14-mar-2024.Expiration date: 2029-02-26.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.
Event or Problem Description
At about 1 month and 3 weeks after primary, the patient has been revised because of infection.The surgeon revised successfully the impact dm converter, dm liner and ceramic femoral head and implanted a poly hooded liner and cocr femoral head.

• Brand Name: MPACT DM DM CONVERTER TIN COATED F/DME
• Common Device Name: MPACT LINER, CONVERTER TO DOUBLE MOBILITY
• 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: 19642081
• Report Number: 3005180920-2024-00464
• Device Sequence Number: 8673599
• Product Code: LZO
• UDI-Device Identifier: 07630971256361
• UDI-Public: 07630971256361
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K211891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 07/01/2024

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 Catalogue Number: 01.32.4248CF
• Device Lot Number: 2317571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• 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: Required Intervention
• Patient Sex: Female