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	02/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2018 lot 174269:7 (b)(4) items manufactured and released on 22 november 2017.Expiration date: 2022-11-13.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.Mpact flat pe hc liner ø 36/e reference 01.32.3644hct.Lot 174523: (b)(4) items manufactured and released on 15 december 2017.Expiration date: 2022-11-27.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.Mpact cancellous bone screw, flat head ø 6,5 l 40 reference 01.32.6540.Lot 172444: (b)(4) items manufactured and released on 31 august 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.Amistem h ha coated std stem size 2 reference 01.18.132.Lot 170810: (b)(4) items manufactured and released on 17 july 2017.Expiration date: 2022-07-04.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.Mectacer biolox delta ceramic ball head 12/14 ø 36 size m 0 reference 01.29.209.Lot 174720: (b)(4) items manufactured and released on 15 november 2017.Expiration date: 2022-11-06.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.
Event or Problem Description
About 8 month after primary the surgeon revised the patient for a hip infection.All hardware removed.The surgery was completed 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: 8069025
• Report Number: 3005180920-2018-00901
• Device Sequence Number: 14000757
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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: 11/13/2022
• Device Catalogue Number: 01.32.154DH
• Device Lot Number: 174269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/14/2018
• 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