MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø52 NO-HOLE; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.32.152SH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 apr 2019: lot 184599: (b)(4) items manufactured and released on 19-oct-2018.Expiration date: 2023-10-10.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: liner: mpact 01.32.3244hct flat pe hc liner ø32/e (k103721), lot 186965: (b)(4) items manufactured and released on 09-oct-2018.Expiration date: 2023-09-24.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 01.18.414 amistem-p lat stem size 4 (k173794), lot 179949: 139 items manufactured and released on 03-may-2018.Expiration date: 2023-04-23.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 01.29.231h head biolox option ø 32 (k131518) [implanted on (b)(6) 2019, during the first revision reported in the mdr 2019-00290].Lot 186574: (b)(4) items; manufactured and released on 12-nov-2018.Expiration date: 2023-10-28.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 01.29.241a sleeve size m (k131518) [implanted on (b)(6) 2019, during the first revision reported in the mdr 2019-00290].Lot 183383: (b)(4); items manufactured and released on 25-jul-2018.Expiration date: 2023-07-16.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 13 days after the previous revision (performed washout and head revision also due to an infection, mdr 2019-00290) due to an infection (the pathogen has been identified as staphylococcus).The surgeon performed a washout and revised the stem, head, liner, and cup.The surgery was completed successfully.The primary case was performed on (b)(6) 2019.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø52 NO-HOLE
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8573535
• Report Number: 3005180920-2019-00330
• Device Sequence Number: 11231752
• Product Code: LPH
• UDI-Device Identifier: 07630030810817
• UDI-Public: 07630030810817
• 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): 05/02/2019

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: 10/10/2023
• Device Catalogue Number: 01.32.152SH
• Device Lot Number: 184599
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 05/02/2019
• 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