MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø48; ANATOMICAL GLENOID

Catalog Number	04.01.0132
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25-july-2019: lot 181490: (b)(4) items manufactured and released on 13-jun-2018.Expiration date: 2023-06-03.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: unexpected early pain in primary tsa after less than 1 year.The source or cause of pain cannot be ascertained with the information supplied - the system looks correctly implanted and no trauma has been reported.We do not know if the revision surgeon changed position or tension because we have no post-revision xrays.We are unable to determine the cause for this adverse event.Additional implant: anatomical shoulder system 04.01.0026 humeral anatomical metaphysis - cementless - 135° - 9 (k170910), lot.1710037.Batch review performed on 25-july-2019: lot 1710037: (b)(4) items manufactured and released on 25-may-2018.Expiration date: 2023-05-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant: anatomical shoulder system 04.01.0089 double eccenter (k170910), lot.181485.Batch review performed on 25-july-2019: lot 181485: (b)(4) items manufactured and released on 8-may-2018.Expiration date: 2023-04-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant :anatomical shoulder system 04.01.0093 metal humeral head ø46 (k170910) lot.167986.Batch review performed on 25-july-2019: lot 167986: (b)(4) items manufactured and released on 4-may-2017.Expiration date: 2022-04-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed after 11 months from the primary due to pain (the cause of the pain is unknown, there was no trauma).The surgeon revised the humeral head, double eccenter, humeral metaphysis, and hc pegged glenoid successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø48
• Common Device Name: ANATOMICAL GLENOID
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8877722
• Report Number: 3005180920-2019-00668
• Device Sequence Number: 253877
• Product Code: KWS
• UDI-Device Identifier: 07630040713276
• UDI-Public: 07630040713276
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2019

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: 06/03/2023
• Device Catalogue Number: 04.01.0132
• Device Lot Number: 181490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/09/2019
• 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