MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-P QUADRA-P CEMENTED STD STEM SIZE 2; CEMENTED HIP STEM

Model Number	01.12.212
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 may 2021: lot 2011497: (b)(4) items manufactured and released on 04-dec-2020.Expiration date: 2025-11-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: ball heads: bipolar head 25060.2845 bipolar head ø28x45 (k091967) lot.2006642.Batch review performed on 10 may 2021: lot 2006642: (b)(4) items manufactured and released on 16-sept-2020.Expiration date: 2025-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Additional implant involved: ball heads: cocr 01.25.012 cocr ball head 12/14 ø 28 size m 0 (k072857) lot.2006279.Batch review performed on 10 may 2021: lot 2006279: (b)(4) items manufactured and released on 25-sept-2020.Expiration date: 2025-09-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
1 month after primary the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the stem, head and bipolar head.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-P QUADRA-P CEMENTED STD STEM SIZE 2
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11876214
• Report Number: 3005180920-2021-00439
• Device Sequence Number: 14360747
• Product Code: LZO
• UDI-Device Identifier: 07630040732093
• UDI-Public: 07630040732093
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 05/25/2021

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: 11/19/2025
• Device Model Number: 01.12.212
• Device Catalogue Number: 01.12.212
• Device Lot Number: 2011497
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR