MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

Catalog Number	01.32.154DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 may 2019: lot 181635: (b)(4) items manufactured and released on 20-jun-2018.Expiration date: 2023-06-11.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 implants involved: liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721), lot 182615: (b)(4) items manufactured and released on 31-jul-2018.Expiration date: 2023-07-15.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.Screws: mpact 01.32.6520 cancellous bone screw, flat head ø 6,5 l 20 (k103721) lot 184330: (b)(4) items manufactured and released on 18-jul-2018.Expiration date: 2023-07-04.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 stem: quadra-h 01.12.023 cementless, ha coated std stem size 3 (k082792), lot 181753: (b)(4) items manufactured and released on 26-jun-2018.Expiration date: 2023-06-12.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.Ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115), lot 176837: (b)(4) items manufactured and released on 23-feb-2018.Expiration date: 2023-02-08.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.Clinical evaluation performed by medical affairs manager: infection in cementless tha, 5 months after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Preliminary investigation performed by r&d project manager: the images show the implant just explanted from the patient; from the received photos no anomalies seem to be present on the cup.The reason remains unknown but there are no any particular signs to correlate the event to an implant defect.
Event or Problem Description
Revision surgery performed due to infection 5 months after primary.Patient had a reoccurring infection, he had 3 washouts prior with no effect.Aspiration 4 months after primary showed infection.The pathogen is staph epidermidis.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8612051
• Report Number: 3005180920-2019-00385
• Device Sequence Number: 2220803
• Product Code: LPH
• UDI-Device Identifier: 07630030810824
• UDI-Public: 07630030810824
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 05/15/2019

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: 06/11/2023
• Device Catalogue Number: 01.32.154DH
• Device Lot Number: 181635
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/15/2019
• 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
• Patient Age: 60 YR
• Patient Weight: 125