MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 50

Model Number	01.32.150MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 24 july 2020 lot 1909300: (b)(4) items manufactured and released on 17-mar-2020.Expiration date: 2025-03-08, no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported.Other devices involved in the event: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 lot.1906462 (k112115).Batch review performed by medacta regulatory affairs department on 24 july 2020 lot 1906462: (b)(4) items manufactured and released on 31-oct-2019.Expiration date: 2024-10-13, no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 2 similar reported events.Liner: versafitcup dm 01.26.2850mhc double mobility hc liner ø 50/28 lot.1909377 (k092265).Batch review performed by medacta regulatory affairs department on 24 july 2020: lot 1909377: (b)(4) items manufactured and released on 29-jan-2020.Expiration date: 2025-01-08, no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported.
Event or Problem Description
The patient came in 1 month after the primary surgery for a post-op appointment and it was observed that the patient was experiencing tissue breakdown due to an infection.The surgeon revised the head with sleeve, cup and liner.The pathogen is unknown and the surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 50
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10366572
• Report Number: 3005180920-2020-00513
• Device Sequence Number: 19419363
• Product Code: LPH
• UDI-Device Identifier: 07630030860966
• UDI-Public: 07630030860966
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• 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): 08/05/2020

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: 03/08/2025
• Device Model Number: 01.32.150MB
• Device Catalogue Number: 01.32.150MB
• Device Lot Number: 1909300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/05/2020
• 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