MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø54; ANATOMICAL GLENOID

Catalog Number	04.01.0135
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 august 2019: lot 181493: (b)(4) items manufactured and released on 13-jun-2018.Expiration date: 2023-06-03.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 implant involved: anatomical shoulder system 04.01.0092 metal humeral head ø44 (k170910) lot.167985.Batch review performed on 6 august 2019: lot 167985: (b)(4) items manufactured and released on 04-may-2017.Expiration date: 2022-04-17.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.Additional implant involved:anatomical shoulder system 04.01.0089 double eccenter (k170910) lot.183786.Batch review performed on 6 august 2019: lot 183786: (b)(4) items manufactured and released on 19-sep-2018.Expiration date: 2023-09-09.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 implant involved: anatomical shoulder system 04.01.0026 humeral anatomical metaphysis - cementless - 135° - 9 (k170910) lot.1710037.Batch review performed on 6 august 2019: lot 1710037: (b)(4) items manufactured and released on 25-may-2018.Expiration date: 2023-05-13.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.Additional implant involved: anatomical shoulder system 04.01.0182 short humeral diaphysis - cementless - 9 (k180089) lot.172589.Batch review performed on 6 august 2019: lot 172589: (b)(4) items manufactured and released on 15-may-2017.Expiration date: 2022-05-03.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
The patient came in, 12 days after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon performed an i&d and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø54
• Common Device Name: ANATOMICAL GLENOID
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8939222
• Report Number: 3005180920-2019-00711
• Device Sequence Number: 16682184
• Product Code: KWS
• UDI-Device Identifier: 07630040713306
• UDI-Public: 07630040713306
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: 06/03/2023
• Device Catalogue Number: 04.01.0135
• Device Lot Number: 181493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/28/2019
• 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