MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 42XØ27; REVERSE SHOULDER GLENOSPHERE

Model Number 04.01.0212

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Pain (1994)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 15 september 2021: lot 1910958: (b)(4) items manufactured and released on 25-may-2020.Expiration date: 2025-05-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: reverse shoulder system 04.01.0193 threaded glenoid baseplate ø27x35 (k171058) lot.185296.Batch review performed on 14 october 2021.Lot 185296: (b)(4) items manufactured and released on 29-aug-2018.Expiration date: 2023-08-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Preliminary investigation performed by r&d project manager: in the provided x.-rays the glenosphere appears to be dissociated from the baseplate and the screw loose and partially out of its intended position.An analysis of the explants is required to proceed with the research of the root cause.Visual inspection performed by r&d project manager: mild circumferential signs are visible on the flat backsurface of the glenosphere, probably due to friction with a peripheral glenoid screw.It is not possible to state whether the screw was positioned proud form the baseplate after the primary surgery or it backed out in the following months.The liner is damaged on the outer rim of the articular surface, likely due to friction with the scapula prior to or after the glenosphere dissociation.No action is suggested.

Event Description

At 4 months after the primary, the patient came in reporting pain and a grinding feeling in the shoulder.The surgeon took x-rays and it was determined that glenosphere screw and implant were loose.The surgeon revised the lateralized glenosphere and the poly.The surgery was completed successfully.

Manufacturer Narrative

Clinical evaluation: few months after primary rsa the glenosphere is found detached from the baseplate.This is probably due to a proud baseplate fixation screw that prevented the glenosphere from reaching final seating position and engaging the morse taper on the baseplate.We cannot determine how or when this originated: it's rather probable that the baseplate fixation screw was impeded to reach final position for some unknown reason since the time of primary surgery.We do not identify a clinical cause to this adverse event.Once properly replaced, no further clinical consequence should be expected.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 42XØ27
• Type of Device: REVERSE SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12631996
• MDR Text Key: 277117712
• Report Number: 3005180920-2021-00800
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 07630040728119
• UDI-Public: 07630040728119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.01.0212
• Device Catalogue Number: 04.01.0212
• Device Lot Number: 1910958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention