MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL C.A.P. HEAD HA 52X21; GLOBAL CAP IMPLANT : SHOULDER HUMERAL HEADS

Model Number 1230-52-025

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Pocket Erosion (2013)

Event Date 04/27/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision of the right shoulder today at north tees hospital.Prosthesis to be kept at hospital at surgeons request.Revision due to pain and glenoid erosion.Apg+ and global ap implanted today.

Manufacturer Narrative

Product complaint #
=
> (b)(4) investigation summary
=
> no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot
=
> the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: h6 (clinical codes).

• Brand Name: GLOBAL C.A.P. HEAD HA 52X21
• Type of Device: GLOBAL CAP IMPLANT : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11801068
• MDR Text Key: 250237465
• Report Number: 1818910-2021-09889
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295017837
• UDI-Public: 10603295017837
• Combination Product (y/n): N
• PMA/PMN Number: K033516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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
• Device Operator: Health Professional
• Device Model Number: 1230-52-025
• Device Catalogue Number: 123052025
• Device Lot Number: Z5NESA000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLOBAL C.A.P. HEAD HA 52X21; UNK SHOULDER GLENOID GLOBAL APG+
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR