MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 MULTI-HOLE

Catalog Number	01.32.154MH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 2 july 2019: lot 186958: (b)(4) items manufactured and released on 16-"gen"-2019.Expiration date: 2024-01-01.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any other similar reported event.Additional implants involved in the event, batch review performed on 2 july 2019: liner: mpact 01.32.3644hct flat pe hc liner ø36/e lot 1811217 (k103721): (b)(4) items manufactured and released on 1-mar-2019.Expiration date: 2024-02-17.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any other similar reported event.Stem: amistem p 01.18.443 amistem-p collared lat stem size 3, lot: 188032 (k173794): (b)(4) items manufactured and released on 18-"dic"-2018.Expiration date: 2023-12-06.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any other similar reported event.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0, lot: 187086 (k112115): (b)(4) items manufactured and released on 11-"dic"-2018.Expiration date: 2023-11-27.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed after 9 days from the primary due to signs of an infection (the pathogen is unknown).The surgeon explanted all hardware and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø54 MULTI-HOLE
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8793456
• Report Number: 3005180920-2019-00588
• Device Sequence Number: 19343762
• Product Code: LPH
• UDI-Device Identifier: 07630030810831
• UDI-Public: 07630030810831
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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: 01/01/2024
• Device Catalogue Number: 01.32.154MH
• Device Lot Number: 186958
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/16/2019
• 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