MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø56 NO-HOLE; HIP ACETABULAR CUP CEMENTLESS

Model Number	01.32.156SH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/20/2022
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 superficial incision and drainage and no implants were revised.The case was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 2115967: 48 items manufactured and released on (b)(6) 2022.Expiration date: 2027-01-31.No anomalies found related to the problem.To date, 22 items of the same lot have been sold with no similar reported case during the period of review.Lot 2116165: 180 items manufactured and released on (b)(6) 2021.Expiration date: 2026-11-30.No anomalies found related to the problem.To date, 84 items of the same lot have been sold with no similar reported case during the period of review.Lot 2114373: 159 items manufactured and released on (b)(6) 2022.Expiration date: 2026-12-21.No anomalies found related to the problem.To date, 82 items of the same lot have been sold with no similar reported case during the period of review.Lot 2010025: 40 items manufactured and released on (b)(6) 2021.Expiration date: 2025-12-14.No anomalies found related to the problem.To date, 8 items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø56 NO-HOLE
• Common Device Name: HIP ACETABULAR CUP 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: 15028626
• Report Number: 3005180920-2022-00531
• Device Sequence Number: 4763151
• Product Code: LPH
• UDI-Device Identifier: 07630030810886
• UDI-Public: 07630030810886
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2022

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: 01.32.156SH
• Device Catalogue Number: 01.32.156SH
• Device Lot Number: 2115967
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2022
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Race: White