MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 27X15

Model Number	04.01.0154
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 february 2021: lot 2001981: (b)(4) items manufactured and released on 29-apr-2020.Expiration date: 2025-04-15.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
Revision surgery 4 months after primary for base plate loosening.The surgeon revised successfully the patient shoulder replacing the glenoids implants and the humeral reverse hc liner.The glenosphere was found coupled to the baseplate during the revision.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta clinical director: early mobilisation of the glenoid baseplate in primary rsa, few weeks after index surgery.The original baseplate had short peg, this choice was most probably done to preserve bone with a compromise on hold, which is common practice.No reason to suspect a faulty device.
Additional Manufacturer Narrative
Visual inspection performed by r&d manager the baseplate appears to generally have ha residuals on the coated surface, while some spots present bone residuals, following early bony response.The articular surface of the glenosphere is partially scratched due to friction with the reverse metaphysis following baseplate mobilization and subsequent luxation.The glenosphere screw and the glenoid locking screws do not show any signs of damage.No action is suggested.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 27X15
• Common Device Name: GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11473640
• Report Number: 3005180920-2021-00191
• Device Sequence Number: 19752564
• Product Code: PHX
• UDI-Device Identifier: 07630040706414
• UDI-Public: 07630040706414
• 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: 2020
• 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,Followup
• Report Date (Section B): 06/02/2021

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: 04/15/2025
• Device Model Number: 04.01.0154
• Device Catalogue Number: 04.01.0154
• Device Lot Number: 2001981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 02/10/2021; 02/10/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 03/16/2021; 06/02/2021
• 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: 54 YR
• Patient Weight: 85