MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3; HIP STEM CEMENTLESS

Model Number	01.12.23SN
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the primary surgery was performed.After a periprosthetic fracture, the stem, the liner, and the head were revised on (b)(6) 2022.Presently, (b)(6) 2022, revision took place in (b)(6) following infection.The surgeon revised successfully the liner and head.
Additional Manufacturer Narrative
Stem revised in the first revision surgery ((b)(6) 2022) due to femur fracture, head and liner reported below were revised in the second revision surgery ((b)(6) 2022) due to infection.Batch review performed on 27 may 2022.Lot 2111461: (b)(4).Expiration date: 2027-01-10.No anomalies found related to the problem.(b)(4).Additional components involved: liner: versafitcup cc trio 01.26.3644hct flat pe hc liner ø 36 / e (k103352) lot.2114145: (b)(4).Expiration date: 2026-10-28.No anomalies found related to the problem.(b)(4).Ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.2114367: (b)(4).Expiration date: 2026-12-21.No anomalies found related to the problem.(b)(4).
Additional Manufacturer Narrative
Corrected data: stem details and batch review.Batch review performed on 27 may 2022.Lot 2111451: (b)(4) manufactured and released on 25-jan-2022.Expiration date: 2027-01-09.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14641437
• Report Number: 3005180920-2022-00443
• Device Sequence Number: 12185824
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 06/09/2022

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: 01.12.23SN
• Device Catalogue Number: 01.12.023
• Device Lot Number: 2111451
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2022
• 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