MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES; ACETABULAR CUP

Catalog Number	01.32.156DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 august 2019: lot 181124: (b)(4) items manufactured and released on 13-june-2018.Expiration date: 2023-06-04.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: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot.165918.Batch review performed on 20 august 2019: lot 165918: (b)(4) items manufactured and released on 10-nov-2016.Expiration date: 2021-10-23.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: screws: screws: mpact 01.32.6545 cancellous bone screw, flat head ø 6,5 (k103721) l 45, lot.172445.Batch review performed on 20 august 2019: lot 172445: (b)(4) items manufactured and released on 10-may-2017.Expiration date: 2022-04-25.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: screws: mpact 01.32.6525 cancellous bone screw, flat head ø 6,5 l 25 (k103721), lot.173318.Batch review performed on 20 august 2019: lot 173318: (b)(4) items manufactured and released on 05-sept-2017.Expiration date: 2022-08-17.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: stem: amistem p 01.18.405 amistem-p std stem size 5 (k173794), lot.180732.Batch review performed on 20 august 2019: lot 180732: (b)(4) items manufactured and released on 19-giu-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 similar reported event.Additional implant involved: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115), lot.187085.Batch review performed on 20 august 2019: lot 187085: (b)(4) items manufactured and released on 12-dec-2018.Expiration date: 2023-12-03.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
About 1 month and a half after primary surgery the surgeon revised the patient hip for infection.The pathogen is unknown, all implants revised successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8955359
• Report Number: 3005180920-2019-00748
• Device Sequence Number: 2609282
• Product Code: LPH
• UDI-Device Identifier: 07630030810855
• UDI-Public: 07630030810855
• 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): 09/03/2019

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: 06/04/2023
• Device Catalogue Number: 01.32.156DH
• Device Lot Number: 181124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/03/2019
• 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