MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 52 TWO-HOLES

Model Number	01.32.152DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 10 july 2020: lot 1907400: (b)(4) items manufactured and released on 12-dec -2019.Expiration date: 2024-12-03.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.Other devices involved in the event: liner: mpact 01.32.3644hct flat pe hc liner ø36/e lot.1908279 (k103721).Batch review performed by medacta regulatory affairs department on 10 july 2020: lot 1907400: (b)(4) items manufactured and released on 12-dec -2019.Expiration date: 2024-12-03.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.Ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 lot.1908991 (k112115).Batch review performed by medacta regulatory affairs department on 10 july 2020: lot 1908991: (b)(4) items manufactured and released on 17-feb -2020.Expiration date: 2025-02-03.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.Stem: amistem p 01.18.403 amistem-p std stem #3 lot.1907041 (k173794).Batch review performed by medacta regulatory affairs department on 10 july 2020: lot 1907041: (b)(4) items manufactured and released on 28-nov -2020.Expiration date: 2024-11-17.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.
Event or Problem Description
The patient came in 20 days after the primary surgery due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the medacta cup and liner with another company's product and revised the medacta stem and head with a medacta stem and head.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL 52 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: 10331243
• Report Number: 3005180920-2020-00464
• Device Sequence Number: 16934601
• Product Code: LPH
• UDI-Device Identifier: 07630030810794
• UDI-Public: 07630030810794
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2020

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: 12/03/2024
• Device Model Number: 01.32.152DH
• Device Catalogue Number: 01.32.152DH
• Device Lot Number: 1907400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2020
• Initial Report FDA Received Date: 07/28/2020
• 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: 67 YR