MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 54 TWO-HOLES

Model Number	01.32.154DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 26 june 2020 lot 165661: (b)(4) items manufactured and released on 17-oct-2016.Expiration date: 2021-10-06.No anomalies found related to the problem.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Lot 174523: (b)(4) items manufactured and released on 15-dec-2017.Expiration date: 2022-11-27.No anomalies found related to the problem.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one other similar reported event.Lot 174721: (b)(4) items manufactured and released on 22-nov-2017.Expiration date: 2022-11-12.No anomalies found related to the problem.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Lot 171661: (b)(4) items manufactured and released on 10-jul-2017.Expiration date: 2022-06-19.No anomalies found related to the problem.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in 2 years and 4 months after the primary surgery due to signs of infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL 54 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10271040
• Report Number: 3005180920-2020-00408
• Device Sequence Number: 16987043
• Product Code: LPH
• UDI-Device Identifier: 07630030810824
• UDI-Public: 07630030810824
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

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: No Information
• Device Expiration Date: 10/06/2021
• Device Model Number: 01.32.154DH
• Device Catalogue Number: 01.32.154DH
• Device Lot Number: 165661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 07/14/2020
• 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: 79 YR