MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA P FEMORAL STEMS; QUADRA-P LAT STEM SIZE 5

Model Number	01.12.145
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17-dec-2024.Lot 2200473: (b)(4) items manufactured and released on 13-jun-2022.Expiration date: 2027-05-29.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.Addiitonal items involved in the event, batch review performed on 17-dec-2024.Liner: versafitcup dm 01.26.2856mhc double mobility hc liner ø 56/28 (k143453) lot.2302834 lot 2302834: (b)(4) items manufactured and released on 12-apr-2023.Expiration date: 2028-03-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.Ball heads: mectacer 01.29.230h head biolox option ø 28 (k131518) lot.2315673 lot 2315673: (b)(4) items manufactured and released on 06-jul-2023.Expiration date: 2028-06-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.Cup: mpact 01.32.156mb double mobility acetabular shell ø56 (k143453) lot.2246659 lot 2246659: (b)(4) items manufactured and released on 31-may-2023.Expiration date: 2028-05-16.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 3 months after primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon removed all medacta hardware and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: QUADRA P FEMORAL STEMS
• Common Device Name: QUADRA-P LAT STEM SIZE 5
• 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: 21033879
• Report Number: 3005180920-2024-01042
• Device Sequence Number: 9155733
• Product Code: LZO
• UDI-Device Identifier: 07630040720571
• UDI-Public: 07630040720571
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181254
• 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): 12/30/2024

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 Model Number: 01.12.145
• Device Lot Number: 2200473
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White