MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27

Model Number 04.01.0173

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 03/16/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 27 march 2020: lot 179114: (b)(4) items manufactured and released on 26-mar-2018.Expiration date: 2023-03-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with other 2 similar reported event.Another device involved in the event: reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm lot.175049 (k170452).Batch review performed on 27 march 2020: lot 175049: (b)(4) items manufactured and released on 27 september 2017.Expiration date: 2022-09-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with other 3 similar reported events.Clinical evaluation performed by medical affairs department: early dislocation few days after surgery.The components remained intact and we cannot detect any hint of a defect that led to the problem.These event may be originated by insufficient re-establishment of soft tissue tension after the operation.The presence of hematoma may also be the cause but this cannot be confirmed on the basis of available documentation.No further conclusion can be drawn with the elements at hand.

Event Description

The surgeon revised the patient 1 week after primary surgery for shoulder dislocation.The surgeon expressed opinion that following root causes might be possible for the dislocation: low deltoid muscle tension due to the small size glenosphere and liner, hematoma, the glenosphere and the liner was replaced during the revision surgery.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27
• Type of Device: REVERSE SHOULDER SYSTEM GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874, sz; SZ
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 -CHE ; SZ 6874 CHE
• MDR Report Key: 9961873
• MDR Text Key: 192243586
• Report Number: 3005180920-2020-00243
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2020

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
• Device Operator: No Information
• Device Expiration Date: 03/08/2023
• Device Model Number: 04.01.0173
• Device Catalogue Number: 04.01.0173
• Device Lot Number: 179114
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/26/2018
• 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: 76 YR
• Patient Weight: 73