MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø46; SHOULDER GLENOID

Catalog Number	04.01.0131
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 september 2019: lot 182675: (b)(4) items manufactured and released on 27-sep-2018.Expiration date: 2023-09-17.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.Other devices involved in the event.Anatomical shoulder system 04.01.0092 metal humeral head ø44 lot.1710137 (k170910) batch review performed on 03 september 2019: lot 1710137: (b)(4) items manufactured and released on 19-jun-2018.Expiration date: 2023-06-10.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 04.01.0089 double eccenter lot.185295 (k170910) batch review performed on 03 september 2019: lot 185295: (b)(4) items manufactured and released on 07-dec-2018.Expiration date: 2023-11-26.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 04.01.0027 humeral anatomical metaphysis - cementless - 135° - 10 lot.1710038, (k170910).Batch review performed on 03 september 2019: lot 1710038: (b)(4) items manufactured and released on 30-may-2018.Expiration date: 2023-05-17.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.
Event or Problem Description
The patient came in, 2 months after primary surgery, complaining of pain due to a torn subscapularis muscle.The cause of the tear is unknown.The surgeon removed the hc pegged glenoid, metal humeral head, double eccenter and humeral anatomical metaphysis-cementless and implanted reverse system implants successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø46
• Common Device Name: SHOULDER GLENOID
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8959608
• Report Number: 3005180920-2019-00739
• Device Sequence Number: 11434891
• Product Code: KWS
• UDI-Device Identifier: 07630040713269
• UDI-Public: 07630040713269
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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: 09/17/2023
• Device Catalogue Number: 04.01.0131
• Device Lot Number: 182675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 09/04/2019
• 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