MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø24.5X25; REVERSE SHOULDER GLENOID BASEPLATE

Catalog Number 04.01.0152

Device Problems Device Slipped (1584); Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/13/2019

Event Type  Injury  

Manufacturer Narrative

Clinical evaluation performed by medical affairs director: early mobilization in a bio-rsa surgery.According to report, the glenoid component moved medially, and that most probably means that the bone graft did not integrate.According to a surgeon comment, it was rather soft, but we cannot assess or quantify this statement nor determine the influence of this qualitative property on the insufficient result of the treatment.However, there is no indication in the report that an implanted device showed any malfunction.Batch review performed on 08 april 2019: lot 179961: (b)(4) items manufactured and released on 28-may-2018.Expiration date: 2023-05-15.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 Description

On (b)(6) 2019 we were informed about a patient who needed a revision surgery 2 months after primary due to the tibial baseplate moved too much medially, maybe because of the very soft bone.On the following day the surgeon revised baseplate, 2 screws, glenosphere, inlay and metaphysis with new sizes.The primary was a bio-rsa surgery.The revision was a bio-rsa as well: they implanted successfully a 27 baseplate with 35peg and 4 screws, 42 glenosphere, 42/0mm inlay, 0 metaphysis.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø24.5X25
• Type of Device: REVERSE SHOULDER GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8498771
• MDR Text Key: 141444204
• Report Number: 3005180920-2019-00261
• Device Sequence Number: 0
• Product Code: PHX
• Reporter Country Code: SZ
• PMA/PMN Number: K170452
• 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
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2023
• Device Catalogue Number: 04.01.0152
• Device Lot Number: 179961
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2018
• 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
• Patient Age: 71 YR