MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMB; HIP SHELL LINER

Model Number	01.26.2244MHC
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 weeks after the primary surgery, the patient came presenting inflamed tissues due to infection.The surgeon revised successfully the head and liner.
Additional Manufacturer Narrative
No analysis could be performed since lot numbers are unknown and devices are not yet returned for inspection.Other device involved: ball heads: inox 25055.2203 ball head 12/14 ø 22 size m 0 (device not distributed in us).
Additional Manufacturer Narrative
Batch review performed on 28-apr-2023: lot 2005740: (b)(4)items manufactured and released on 12-aug-2020.Expiration date: 2025-07-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMB
• Common Device Name: HIP SHELL LINER
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16427658
• Report Number: 3005180920-2023-00096
• Device Sequence Number: 19488343
• Product Code: LZO
• UDI-Device Identifier: 07630030806803
• UDI-Public: 07630030806803
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 05/09/2023

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: 01.26.2244MHC
• Device Catalogue Number: 01.26.2244MHC
• Device Lot Number: 2215518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2022
• 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: Female
• Patient Weight: 44 KG