MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number 1130-02-000

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

Patient Problem Pain (1994)

Event Date 11/24/2020

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

Patient underwent a partial revision right shoulder replacement.The glenoid component was removed and the neck taper and head was changed.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : no anomalies or deviations were found during the review.

• Brand Name: GLOBAL AP 135 DEG TAPER ASSEM
• Type of Device: GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10985083
• MDR Text Key: 220717039
• Report Number: 1818910-2020-26743
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295005438
• UDI-Public: 10603295005438
• Combination Product (y/n): N
• PMA/PMN Number: K060874
• 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: 11/24/2020

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
• Device Operator: Health Professional
• Device Model Number: 1130-02-000
• Device Catalogue Number: 113002000
• Device Lot Number: D23HH1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLOBAL AP HUMERAL HD 48X15 ECC; GLOBAL SHD END PEG GLEN 48; GLOBAL AP HUMERAL HD 48X15 ECC; GLOBAL SHD END PEG GLEN 48
• Patient Outcome(s): Required Intervention