MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28; HIP LINER DOUBLE MOBILITY

Model Number	01.26.2850MHC
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month after the primary surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 2118106: 110 items manufactured and released on 01-feb-2022.Expiration date: 2027-01-19.No anomalies found related to the problem.To date, 71 items of the same lot have been sold with no similar reported cases during the period of review.Additional component involved: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot.2114357: 150 items manufactured and released on 10-jan-2022.Expiration date: 2026-12-21.No anomalies found related to the problem.To date, 105 items of the same lot have been sold with no similar reported cases during the period of review.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28
• Common Device Name: HIP LINER 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15333461
• Report Number: 3005180920-2022-00664
• Device Sequence Number: 20588235
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 09/01/2022

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: 01.26.2850MHC
• Device Catalogue Number: 01.26.2850MHC
• Device Lot Number: 2118106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2022
• 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 Sex: Female