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

Catalog Number	01.32.154DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 january 2019: lot 177614: (b)(4) items manufactured and released on 14 march 2018.Expiration date: 2023-03-05.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Mpact flat pe hc liner ø36/e reference 01.32.3644hct (k103721) lot 177540: (b)(4) items manufactured and released on 14 march 2018.Expiration date: 2023-03-01.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event amistem h ha coated std stem size 6 reference 01.18.136 lot 170023: (b)(4) items manufactured and released on 16 june 2017.Expiration date: 2022-06-01.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Mectacer biolox delta ceramic ball head 12/14 ø 36 size s - 4 reference 01.29.208 (k112115) lot 177699: (b)(4) items manufactured and released on 21 march 2018.Expiration date: 2023-03-11.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in (6 months after primary surgery) due to signs of infection and the pathogen is unknown.The surgeon explanted the cup, head, liner and stem and implanted an antibiotic spacer.The surgery was performed successfully.

• Brand Name: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8217187
• Report Number: 3005180920-2018-01061
• Device Sequence Number: 18889325
• Product Code: LPH
• UDI-Device Identifier: 07630030810824
• UDI-Public: 07630030810824
• 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: 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): 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2023
• Device Catalogue Number: 01.32.154DH
• Device Lot Number: 177614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 01/04/2019
• 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