MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-P COLLARED STD STEM SIZE 4; HIP STEM

Catalog Number	01.12.164
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-jan-2024.Lot 2249416: (b)(4) items manufactured and released on 05-may-2023.Expiration date: 2028-04-16.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.Additional components involved in the event: batch review performed on 11-jan-2024.Ball heads: mectacer 01.29.231h head biolox option ø 32 (k131518) lot 2315674: (b)(4) items manufactured and released on 05-jul-2023.Expiration date: 2028-06-12.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 01.29.240a sleeve size s (k131518) lot 2305476: (b)(4) items manufactured and released on 12-apr-2023.Expiration date: 2028-03-19.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.Liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot 2306397: (b)(4) items manufactured and released on 03-may-2023.Expiration date: 2028-04-11.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 3d metal 01.38.350mh acetabular shell ø50 multi-hole thin (k202568) lot 2207371: (b)(4) items manufactured and released on 23-jun-2022.Expiration date: 2027-06-03.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.
Event or Problem Description
At about 2 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised all components.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-P COLLARED STD STEM SIZE 4
• Common Device Name: HIP STEM
• 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: 18612969
• Report Number: 3005180920-2024-00019
• Device Sequence Number: 2441382
• Product Code: LZO
• UDI-Device Identifier: 07630040731881
• UDI-Public: 07630040731881
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K192827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/31/2024

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: 01.12.164
• Device Lot Number: 2249416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2023
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 132 KG
• Patient Race: White