MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48; ACETABULAR CUP DOUBLE MOBILITY

Model Number	01.32.148MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 july 2020: lot 1909298: (b)(4) items manufactured and released on 17-mar-2020.Expiration date: 2025-03-09.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: versafitcup dm 01.26.2848mhc double mobility hc liner 48/28 (k092265) lot.1909376 batch review performed on 22 july 2020 lot 1909376: (b)(4) items manufactured and released on 29jan2020.Expiration date: 2025-01-13.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 01.29.202 biolox delta ceramic ball head 12/14 28 size m 0 (k112115) lot.1906462 batch review performed on 22 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 already sold with one similar event reported.Additional implant involved: stem: amistem p 01.18.399 amistem-p std stem size 00 (k173794) lot.1900059.Batch review performed on 22 july 2020: lot 1900059: (b)(4) items manufactured and released on 16-apr-2019.Expiration date: 2024-04-07.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 due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and removed all components 1 month after primary.An antibiotic spacer was implanted and the surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48
• Common Device Name: ACETABULAR CUP DOUBLE MOBILITY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10354778
• Report Number: 3005180920-2020-00489
• Device Sequence Number: 950917
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

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: 03/09/2025
• Device Model Number: 01.32.148MB
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 1909298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/03/2020
• 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