MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø48; HC GLENOID

Catalog Number	04.01.0132
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 october 2018.Lot 168115: (b)(4) items manufactured and released on 10 may 2017.Expiration date: 2022-04-10.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.Other components explanted during the revision: anatomical shoulder system 04.01.0089 double eccenter, lot 181485: (b)(4) items manufactured and released on 08 may 2018.Expiration date: 2022-04-10.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.Anatomical shoulder system 04.01.0184 short humeral diaphysis - cementless - 11, lot 171545: (b)(4) items manufactured and released on 04 may 2017.Expiration date: 2022-04-10.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.Anatomical shoulder system 04.01.0028 humeral anatomical metaphysis - cementless - 135° - 11, lot 167952: (b)(4) items manufactured and released on 28 march 2017.Expiration date: 2022-04-10.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.Anatomical shoulder system 04.01.0094 metal humeral head ø48, lot 1710025: (b)(4) items manufactured and released on 23 april 2018.Expiration date: 2022-09-24.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
On sep 7, 2018 we were informed that a revision surgery was planned for (b)(6) 2018 due to infection detected 2 weeks after a previous revision due to shoulder luxation.The revision was performed successfully.The pathogen results are not available.

• Brand Name: ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø48
• Common Device Name: HC GLENOID
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7938077
• Report Number: 3005180920-2018-00757
• Device Sequence Number: 13969152
• Product Code: KWS
• UDI-Device Identifier: 07630040713276
• UDI-Public: 07630040713276
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170910
• 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): 10/05/2018

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: 04/10/2022
• Device Catalogue Number: 04.01.0132
• Device Lot Number: 168115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/05/2018
• 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
• Patient Age: 78 YR