MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25; SHOULDER THREADED GLENOID BASEPLATE

Catalog Number	04.01.0190
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 june 2019: lot: 185488: (b)(4) items manufactured and released on 30 august 2018.Expiration date: 2023-08-21.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: few weeks after primary rsa the glenoid component got loose, reportedly because it had not been possible to get good screw hold at index surgery.There is no reason to think that the cause for loosening is to be sought in a defective device.Other implants involved in the event: batch review performed on 18 june 2019: reverse shoulder system 04.01.0169 glenosphere 36xø24.5, lot: 179109 (k170452).Lot 179109: (b)(4) items manufactured and released on 21 march 2018.Expiration date: 2023-03-08.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm lot.173420 (k170452).Lot 173420: (b)(4) items manufactured and released on 04 july 2017.Expiration date: 2022-06-18.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold with 2 similar reported event.
Event or Problem Description
About 3 months after primary the entire glenoid construct (baseplate, screws and glenosphere) loosened and dislocated as a unit.Glenosphere dislocated from liner.The surgeon pulled the entire construct out as a unit (base plate was loose from the bone).The surgeon removed and replaced the screws, threaded baseplate, humeral liner and the humeral metaphysis.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25
• Common Device Name: SHOULDER THREADED GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8721214
• Report Number: 3005180920-2019-00496
• Device Sequence Number: 13874301
• Product Code: PHX
• UDI-Device Identifier: 07630040708098
• UDI-Public: 07630040708098
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171058
• 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): 06/21/2019

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: 08/21/2023
• Device Catalogue Number: 04.01.0190
• Device Lot Number: 185488
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/21/2019
• 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