MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ22

Catalog Number	04.01.0168
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 june 2018.Lot 174726: 73 items manufactured and released on 08 november 2017.Expiration date: 2022-10-19.No anomalies found related to the problem.To date, 5 items of the same lot have been already sold without any similar reported event.Reverse shoulder system humeral reverse hc liner ø36/+0mm reference (b)(4); lot 173417: 78 items manufactured and released on 27 june 2017.Expiration date: 2022-06-08; no anomalies found related to the problem.To date, 45 items of the same lot have been already sold without any similar reported event.Visual inspection performed by r&d product manager on (b)(4) 2018 the visual inspection confirms that the glenosphere reports scratches on the articular surface.No signs of breakage are visible on the outer border of the reverse liner.No root case can be identified on the investigated implants clinical evaluation performed by medical affairs director on (b)(4) 2018 recurrent dislocation of reverse shoulder arthroplasty 3 months after primary implantation.This event may be due to soft tissue deficiency , resulting in failure to provide sufficient stability.The insert was exchanged to a thicker one to recreate soft tissue tension.The implanted components did not mobilize, nor did they fail in any way.No information on the origin of scratches on the glenosphere is available.
Event or Problem Description
Revision 3 months after primary due to recurrent dislocations; primary surgery performed on (b)(6) 2018.The surgeon revised the 36/0 liner (in position 145°) with a 36/+3 liner (in position 155°) to obtain a good stability.He also revised the glenosphere as it had a slight scratch.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ22
• Common Device Name: GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7596016
• Report Number: 3005180920-2018-00419
• Device Sequence Number: 19381614
• Product Code: PHX
• UDI-Device Identifier: 07630040706551
• UDI-Public: 07630040706551
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

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: 10/19/2022
• Device Catalogue Number: 04.01.0168
• Device Lot Number: 174726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 98