MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES

Model Number	01.32.156DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 8 june 2020: lot 1901382: (b)(4) items manufactured and released on 21-jun-2019.Expiration date: 2024-06-11.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: liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot.1810221.Batch review performed by medacta regualtory affairs department on 8 june 2020: lot 1810221: (b)(4) items manufactured and released on 18-dec-2018.Expiration date: 2023-12-04.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: stem: amistem p 01.18.404 amistem-p std stem size 4 (k173794) lot.1902226.Batch review performed by medacta regualtory affairs department on 8 june 2020: lot 1902226: (b)(4) items manufactured and released on 18-jun-2019.Expiration date: 2024-06-10.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: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot.1811842.Batch review performed by medacta regualtory affairs department on 8 june 2020: lot 1811842: (b)(4) items manufactured and released on 08-apr-2019.Expiration date: 2024-03-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.
Event or Problem Description
The patient came in 7 months after the primary surgery due to signs of infection and the pathogen has been identified as (b)(6).The surgeon performed washout, removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10183416
• Report Number: 3005180920-2020-00361
• Device Sequence Number: 909098
• Product Code: LPH
• UDI-Device Identifier: 07630030810855
• UDI-Public: 07630030810855
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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: Health Professional
• Device Expiration Date: 06/11/2024
• Device Model Number: 01.32.156DH
• Device Catalogue Number: 01.32.156DH
• Device Lot Number: 1901382
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/23/2020
• 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: 62 YR