MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L22

Model Number	04.01.0159
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 july 2020: lot 174282: (b)(4) items manufactured and released on 13-nov-2018.Expiration date: 2022-11-02.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.2 devices of this lot involved in the complaint.Other devices involved on the event: reverse shoulder system 04.01.0157 glenoid polyaxial locking screw - l14 lot.174280 (k170452).Batch review performed on 21 july 2020: lot 174280: (b)(4) items manufactured and released on 13-nov-2017.Expiration date: 2022-11-01.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.Reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 lot.174284 (k170452).Batch review performed on 21 july 2020: lot 174284: (b)(4) items manufactured and released on 12-oct-2017.Expiration date: 2022-10-08.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.Reverse shoulder system 04.01.0172 glenosphere 36x27 lot.163802 (k170452).Batch review performed on 21 july 2020: lot 163802: (b)(4) items manufactured and released on 20-dec-2016.Expiration date: 2011-11-06.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.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° lot.174648 (k170452).Batch review performed on 21 july 2020: lot 174648: (b)(4) items manufactured and released on 06-dec-2017.Expiration date: 2022-11-27.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.Reverse shoulder system 04.01.0119 humeral reverse hc liner 36/+0mm lot.173420 (k170452) batch review performed on 21 july 2020: lot 173420: (b)(4) items manufactured and released on 04-jul-2017.Expiration date: 2022-06-18.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.Reverse shoulder system 04.01.0154 glenoid baseplate ø27x15 lot.163781 (k170452).Batch review performed on 21 july 2020: lot 163781: (b)(4) items manufactured and released on 15-dec-2016.Expiration date: 2021-08-21.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 or Problem Description
During the first surgery (2018) there was an intra-op caudal glenoid fracture during the implantation of an inverse shoulder implant.The surgeon reported to agent that he has in such cases 2 options: 1) go for a hemi prothesis or 2) go for an inverse prothesis but implant it too cranial and then later revise the glenoid side for a anatomic position after fracture healing and in case of problem.The surgeon has chosen option 2 to go on.This revision of today was the revision of the option 2 - a "planned revision".The surgeon told me that the revision is not implant related.Diaphysis was not removed.All other components were removed and sent to sonification (why not available).

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L22
• Common Device Name: GLENOID POLYAXIAL LOCKING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10349979
• Report Number: 3005180920-2020-00485
• Device Sequence Number: 14219219
• Product Code: PHX
• UDI-Device Identifier: 07630040706469
• UDI-Public: 07630040706469
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2020

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
• Operator of Device: No Information
• Device Expiration Date: 11/02/2022
• Device Model Number: 04.01.0159
• Device Catalogue Number: 04.01.0159
• Device Lot Number: 174282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/31/2020
• 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: 79 YR