MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X27 LOT. 189945; SHOULDER GLENOSPHERE

Model Number	04.01.0211
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29.March.2021: lot 189945: (b)(4) items manufactured and released on 14-may-2019.Expiration date: 2024-05-01.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 device involved: batch review performed on 29.March.2021: reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot 2005457: (b)(4) items manufactured and released on 29-jul-2020.Expiration date: 2025-07-14.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
2 months after the previous revision surgery (the patient dislocated multiple times and was treated with closed reduction and finally the liner and glenosphere were revised to give less offset) the patient came in due to another dislocation of the glenosphere from the liner (the patient broke into a parkinson's attack and dislocated his shoulder): the following implants were removed: glenosphere, screws, baseplate and humeral metaphysis.The primary surgery was performed on (b)(6) 2021.
Additional Manufacturer Narrative
Visual inspection performed by medacta shoulder r&d project manager: the visual inspection was performed on 28th april 2021.The articular surface of the glenosphere is partially dull, probably due to friction with the humeral components after the shoulder dislocation.The glenosphere screw does not present any signs of damage or scratches.The glenoid baseplate has bone residuals at the bone-implant interface.The three glenoid locking screws present mild discolouration on the first 1-2 pitches, presumably due to friction with the baseplate during the hardware removal.The reverse metaphysis shows bone residuals on the ha coated surface.The outer surface is partially dull, likely caused by friction with the glenosphere after the shoulder dislocation.The reverse metaphysis screw shows circular scratches on the outer surface.The liner does not present any signs of damage.No action is suggested.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X27 LOT. 189945
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11654731
• Report Number: 3005180920-2021-00299
• Device Sequence Number: 3606446
• Product Code: HSD
• UDI-Device Identifier: 07630040728102
• UDI-Public: 07630040728102
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: 05/01/2024
• Device Model Number: 04.01.0211
• Device Catalogue Number: 04.01.0211
• Device Lot Number: 189945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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: 61 YR
• Patient Weight: 95