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

Model Number	04.01.0155
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-mar-2020: lot 163783: (b)(4) items manufactured and released on 15-dec-2016.Expiration date: 29.08.2021.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot.165152.Batch review performed on 11-mar-2020.We do not know the correct lot of the broken screw.Lot 165152: (b)(4) items manufactured and released on 15-dec-2016.Expiration date: 03.11.2021.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: reverse shoulder system 04.01.0165 glenoid polyaxial locking screw - l46 (k170452) lot.165156.Batch review performed on 11-mar-2020.We do not know the correct lot of the broken screw.Lot 165156: (b)(4) items manufactured and released on 15-dec-2016.Expiration date: 03.11.2021.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed due to glenoid baseplate loosening and polyaxial screw breakage (body) after about 3 years.The patient is a retired gymnast, he is very active.
Additional Manufacturer Narrative
Initial fda report sent on 11-mar-2020.On the same day it was noticed that clinical evaluation has not been inserted in the initial report.A follow up including clinical evaluation has been sent on the same day (11-mar-2020).Clinical evaluation performed by medical affairs director 2.5 years after rsa the glenoid components loosens, with a screw fracture.According to report, strenuous sporting activity was performed, which is a condition that may reduce implant longevity.The images supplied are compatible with an excessive stressful situation.No other possible loosening reasons can be imagined with the data supplied.
Additional Manufacturer Narrative
Devices returned on (b)(6) 2020 and analyzed on (b)(6) 2020 visual inspection performed by r&d project manager.The visual inspection was performed on (b)(6).The baseplate shows no bone residuals.One locking screw is locked in one spherical seat (no possibility to move it).The screw is broken about 1 cm from the screw head.The second screw, provided disassembled from the baseplate, does not show any signs of damage.The glenosphere presents mild scratches on the articular surface.The outer surface of the glenosphere screw is mildly scratched.The outer surface of the reverse liner presents massive damage, presumably due to friction with the scapula.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 27X25
• Common Device Name: REVERSE GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9818114
• Report Number: 3005180920-2020-00144
• Device Sequence Number: 11150876
• Product Code: PHX
• UDI-Device Identifier: 07630040706421
• UDI-Public: 07630040706421
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2020

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: Health Professional
• Device Expiration Date: 08/29/2021
• Device Model Number: 04.01.0155
• Device Catalogue Number: 04.01.0155
• Device Lot Number: 163783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020; 02/12/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 03/11/2020; 07/17/2020
• 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: 69 YR