MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ27

Catalog Number 04.01.0172

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 10 october 2018.Lot 174278: (b)(4) items manufactured and released on 28 august 2017.Expiration date: 2022-08-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.Reverse shoulder system humeral reverse hc liner ø36/+3mm reference 04.01.0120 (k170452).Lot 175045: (b)(4) items manufactured and released on 27 september 2017.Expiration date: 2022-09-07.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.Clinical evaluation performed by medical affairs director on 10 october 2018: few days after primary rsa the artificial joint dislocated.The components remained intact and we cannot detect any hint of a defect that led to the problem.These events are normal originated by progression of disease to the soft tissues or insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.

Event Description

The 23 days after primary the surgeon revised the patient for a luxation.The poly liner luxate from the glenosphere.The surgery was completed successfully.

Manufacturer Narrative

On 04 dec 2018 it was noticed a typo in the batch review of the lot 175045, that has been updated as following: lot 175045: (b)(4) items manufactured and released on 27 september 2017.Expiration date: 2022-09-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 3 similar reported event.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ27
• Type of Device: GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7951006
• MDR Text Key: 123197486
• Report Number: 3005180920-2018-00769
• Device Sequence Number: 0
• Product Code: PHX
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

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: 08/28/2017
• Device Catalogue Number: 04.01.0172
• Device Lot Number: 174278
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 09/10/2018
• Supplement Dates FDA Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR