MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE

Catalog Number	01.32.152MH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 november 2019: lot 1900203: 50 items manufactured and released on 13-june-2019.Expiration date: 2024-05-29.No anomalies found related to the problem.To date, 32 items of the same lot have been already sold without any similar reported event.Additional implants involved in the event, batch review performed on 11 november 2019 screws: impact 01.32.6535 cancellous bone screw, flat head ø 6,5 l 35 (k103721) lot.185348 lot 185348: 110 items manufactured and released on 20-july-2018.Expiration date: 2023-07-11.No anomalies found related to the problem.To date, 77 items of the same lot have been already sold without any similar reported event.Screws: impact 01.32.6525 cancellous bone screw, flat head ø 6,5 l 25 (k103721) lot.1900967 lot 1900967: 200 items manufactured and released on 21-mar-2019.Expiration date: 2024-03-09.No anomalies found related to the problem.To date, 150 items of the same lot have been already sold without any similar reported event.Liner: impact 01.32.3644hcat hooded pe hc liner ø36/e (k132879) lot.1810227.Lot 1810227: 50 items manufactured and released on 20-dec-2018.Expiration date: 2023-12-05.No anomalies found related to the problem.To date, 34 items of the same lot have been already sold without any similar reported event.Screws: impact 01.32.6530 cancellous bone screw, flat head ø 6,5 l 30 (k103721) lot.1902135 lot 1902135: 450 items manufactured and released on 2-apr-2019.Expiration date: 2024-03-19.No anomalies found related to the problem.To date, 304 items of the same lot have been already sold without any similar reported event.Stem: amistem p 01.18.403 amistem-p std stem size 3 (k173794) lot.180727.Lot 180727: 180 items manufactured and released on 13-jun-2018.Expiration date: 2023-06-05.No anomalies found related to the problem.To date, 165 items of the same lot have been already sold without any similar reported event.Ball heads: cocr 01.25.031 cocr ball head 12/14 ø 36 size m 0 (k080885) lot.147314.Lot 147314: 100 items manufactured and released on 3-mar-2015.Expiration date: 2023-06-05.No anomalies found related to the problem.To date, 89 items of the same lot have been already sold with one similar reported event.
Event or Problem Description
Washout performed after 2 months from the primary due to signs of an infection (the pathogen is unknown).The surgeon performed a washout and did not explant any implants.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9376095
• Report Number: 3005180920-2019-00995
• Device Sequence Number: 3090496
• Product Code: LPH
• UDI-Device Identifier: 07630030810800
• UDI-Public: 07630030810800
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2019

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: 05/29/2024
• Device Catalogue Number: 01.32.152MH
• Device Lot Number: 1900203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/26/2019
• 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