MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES

Model Number	01.32.150DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 august 2020: lot 1907397: (b)(4) items manufactured and released on 20-nov-2019.Expiration date: 2024-11-19.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.Additional items involved in the event, batch review performed on 26 august 2020.Ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.1908987.Lot 1908987: (b)(4) items manufactured and released on 19-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 other similar reported event.Liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.1907429.Lot 1907429: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-09-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Stem: amistem c 01.18.100 cemented lat stem size 0 (k103189) lot.181666.Lot 181666: (b)(4) items manufactured and released on 19-jun-2018.Expiration date: 2023-06-06.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 due to signs of an infection and the pathogen is unknown.The surgeon removed all components and revised with a competitor's system 16 days after primary.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10546260
• Report Number: 3005180920-2020-00620
• Device Sequence Number: 3032638
• Product Code: LPH
• UDI-Device Identifier: 07630030810763
• UDI-Public: 07630030810763
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2020

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 Model Number: 01.32.150DH
• Device Catalogue Number: 01.32.150DH
• Device Lot Number: 1907397
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/17/2020
• 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