MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 11; CEMENTLESS HUMERAL DIAPHYSIS

Catalog Number	04.01.0006
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 december 2018: lot 176939: (b)(4) items manufactured and released on 27-feb-2018.Expiration date: 2023-02-14.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 components explanted: reverse shoulder system 04.01.0110, humeral reverse metaphysis +0mm/0°, lot 174650: (b)(4) items manufactured and released on 05-february-2018.Expiration date: 2023-01-25.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.Reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm, lot 179981: (b)(4) items manufactured and released on 24-april-2018.Expiration date: 2023-04-08.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.Due to an human error, the complaint has been reported 1 day in delay to fda (dec 20, 2018 instead of dec 19, 2018).
Event or Problem Description
Revision surgery due to infection 3 weeks after the primary surgery.The surgeon revised the metaphysis, humeral stem and inlay.

• Brand Name: REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 11
• Common Device Name: CEMENTLESS HUMERAL DIAPHYSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8184351
• Report Number: 3005180920-2018-01027
• Device Sequence Number: 19253509
• Product Code: PHX
• UDI-Device Identifier: 07630040706056
• UDI-Public: 07630040706056
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• 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): 12/20/2018

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: 02/14/2023
• Device Catalogue Number: 04.01.0006
• Device Lot Number: 176939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/20/2018
• 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