MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 27X25

Model Number	04.01.0155
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 july 2020.Lot 1811890: (b)(4) items manufactured and released on 06-may-2019.Expiration date: 21-apr-2024.No anomalies found related to the problem to date, 58 items of the same lot have been already sold without any other similar reported event.Clinical evaluation: bone fracture and consequent dislocation in an elderly rsa patient, few days after surgery.The operation involved glenoid reconstruction with humeral bone graft (bio-rsa), but the bone was reportedly too weak and never healed properly.This accident is not to be attributed to a faulty device.
Event or Problem Description
Revision surgery performed due to bone fracture at the level of the baseplate, posteriorly.It caused the shoulder luxation.The primary intervention was with b2 glenoid, bio rsa with angle correction, weak bone and various secondary diseases of the patient (b)(6).

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 27X25
• Common Device Name: GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10282567
• Report Number: 3005180920-2020-00419
• Device Sequence Number: 485098
• Product Code: PHX
• UDI-Device Identifier: 07630040706421
• UDI-Public: 07630040706421
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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: No Information
• Device Expiration Date: 04/21/2024
• Device Model Number: 04.01.0155
• Device Catalogue Number: 04.01.0155
• Device Lot Number: 1811890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/16/2020
• 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: 83 YR