MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM; SHOULDER HUMERAL LINER

Model Number	04.01.0124
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 may 2022.Lot 2103929: (b)(4) items manufactured and released on 28-may-2021.Expiration date: 2026-may-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional device involved.Batch review performed on 20 may 2022: reverse shoulder system 04.01.0208 lat.Glenosphere 39xø24.5 (k193175) lot 2003977: (b)(4) items manufactured and released on 25-mar-2021.Expiration date: 2026-mar-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation performed by medacta clinical affairs specialist: second revision 6 months after the primary rsa in a female patient due to dislocation of the joint.About 3 months after the primary surgery, the patient was revised due to joint dislocation.According to report, about 20 days after the first revision, the joint dislocated again during physiotherapy: the glenosphere, metaphysis and liner were revised.Probably low articular tension and problems with soft tissue management are at the origin of this problem.No reason to suspect that this event is due to a faulty device.
Event or Problem Description
About 3 months after the primary surgery, the patient was revised due to joint dislocation (all components revised except for the baseplate).About 20 days after the first revision, the joint dislocated again during physiotherapy (metaphysis and liner revised).During this revision, it was noted that the prosthesis was not reducing because of soft and residual tissues (eg of trachitis) that interposed in the posterior part and kept the joint dislocated anteriorly.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM
• Common Device Name: SHOULDER HUMERAL LINER
• 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: 14684867
• Report Number: 3005180920-2022-00469
• Device Sequence Number: 4818294
• Product Code: PHX
• UDI-Device Identifier: 07630040706315
• UDI-Public: 07630040706315
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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: 04/11/2026
• Device Model Number: 04.01.0124
• Device Catalogue Number: 04.01.0124
• Device Lot Number: 2103929
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Hispanic
• Patient Race: White