MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25

Catalog Number	04.01.0155
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 july 2019: lot 175039: (b)(4) items manufactured and released on 07-mar-2018.Expiration date: 2023-02-26.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.Preliminary investigation performed by r&d project manager: based on the provided picture of the explanted devices, the following considerations can be done: one screw is broken at about 1.5cm below the head; the inner screw was removed, presumably during the screw removal; the head of the second screw was broken, presumably during the removal; the baseplate does not show any major signs of damage; no massive bone residuals are visible on the central post; the liner, the glenosphere and the glenosphere screw do not show any signs of damage.No considerations about the event root cause can be done.Clinical evaluation performed by medical affairs director: revision surgery performed 6 months after reverse shoulder arthroplasty in a (b)(6) year old man.Patient general health status, comorbidity and level of activity are unknown.In the images provided, the glenoid component looks tilted, inferior screw is broken and radiolucent area over the central peg is visible.It seem that a caudal to cranial force has been applied to the implant and this caused the tilt of the glenoid baseplate and screw breakage.An unexpected movement of the patient in addition to possible poor bone quality may be the cause of the event.The reason of this failure cannot be determined.Additional implant involved in the event, batch review performed on 10 july 2019: reverse shoulder system 04.01.0164 glenoid polyaxial locking screw - l42 (k170452) lot.174751.Lot 174751: (b)(4) items manufactured and released on 30-jan-2018.Expiration date: 2023-01-16.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
After about 5 months from the primary surgery, shoulder revision surgery performed for baseplate mobilization and polyaxial locking screw breakage.The surgeon revised successfully the baseplate, the glenosphere, the liner and the screws.
Additional Manufacturer Narrative
On november 27th 2019 we have received the stem and head involved in the complaint.Visual inspection performed by r&d shoulder manager: preliminary investigation confirmed during visual inspection."based on the provided picture of the explanted devices, the following considerations can be made: one screw is broken at about 1.5cm below the head; the inner screw was removed, presumably during the main screw removal; the head of the second screw was broken, presumably during the removal; the baseplate does not show any major signs of damage; no massive bone residuals are visible on the central post; the liner, the glenosphere and the glenosphere screw do not show any signs of damage.No considerations about the event root cause can be made.".

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25
• Common Device Name: GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8830085
• Report Number: 3005180920-2019-00614
• Device Sequence Number: 3294864
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 02/26/2023
• Device Catalogue Number: 04.01.0155
• Device Lot Number: 175039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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
• Patient Age: 62 YR