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

Model Number	04.01.0173
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022: lot 174736: 148 items manufactured and released on (b)(6) 2017.Expiration date: 2022-09-27.No anomalies found related to the problem.To date, 119 items of the same lot have been sold without any similar reported event during the period of review.Additional item involved in the complaint, batch review performed on (b)(6) 2022: reverse shoulder system 04.01.0154 glenoid baseplate ø27x15 (k170452) lot.175034 lot 175034: 100 items manufactured and released on (b)(6) 2017.Expiration date: 2022-11-09.No anomalies found related to the problem.To date, 60 items of the same lot have been sold with another similar reported event during the period of review.
Event or Problem Description
Revision surgery at about 4 years and 3 months post primary for glenosphere intraprosthetic dislocation from the baseplate.During the primary surgery one of the glenosphere polyaxial screw prong deformed.
Additional Manufacturer Narrative
Clinical evaluation performed on (b)(6) 2022 by medacta medical affairs director: 4 years after primary rsa, the patient makes a sudden physical effort and the glenosphere detaches from the baseplate.At index surgery, due to hard bone, one baseplate screw fixation broke and could not be driven fully in the countersunk seating.This most probably did not allow the glenosphere to reach its final position and therefore the conical coupling was weakened.This is confirmed by the markings on the backsurface of the glenosphere.The damages to the humeral insert are compatible with the disassociated glenosphere.Visual inspection performed on 25 august 2022 by medacta r&d shoulder project manager: the glenosphere shows circular markings on the spherical baksurface.Given the defined and precise geometry, the markings are likely due to friction with at least one peripheral screw protruding from the glenoid baseplate.It is not possible to determine whether the contact happened with the screw object of a precedent complaint on the same patient in per operative (during the insertion of the superior screw in the primary surgery the prongs deformed and were removed with pliers) or with the inferior one.The glenosphere screw shows circular scratches following friction with the inner bore of the glenosphere.The reverse liner is damaged on the thin side.This is presumably due to friction with the scapula or other bone structures following glenosphere dissociation.No action is suggested.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27
• Common Device Name: SHOULDER GLENOSPHERE
• 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: 15247457
• Report Number: 3005180920-2022-00623
• Device Sequence Number: 6341304
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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: 09/27/2022
• Device Model Number: 04.01.0173
• Device Catalogue Number: 04.01.0173
• Device Lot Number: 174736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2017
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 87 KG