MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SHOULDER HUMERAL HEAD GLOBAL

Catalog Number UNK SHOULDER HUMERAL HEAD GLOB

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

Patient Problem Pain (1994)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported this patient had his shoulder replaced approximately 12 years ago by surgeon where he had a global advantage construct implanted.The patient did well until the last few years where cta made his function deteriorate and became painful.Surgeon and the patient decided that revising this construct to a reverse construct would be the best treatment option.Doi: 12 years ago; dor: (b)(6), 2023; affected side: right shoulder.

Event Description

Additional information received states that there was no surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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 - a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK SHOULDER HUMERAL HEAD GLOBAL
• Type of Device: SHOULDER HUMERAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17549812
• MDR Text Key: 321176344
• Report Number: 1818910-2023-16749
• Device Sequence Number: 1
• Product Code: PKC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2023

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 Catalogue Number: UNK SHOULDER HUMERAL HEAD GLOB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 08/15/2023; 08/17/2023
• Supplement Dates FDA Received: 08/16/2023; 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CROSSLINK ANCHOR PG GLENOID 52.; GLOBAL ADVANTAGE STEM 12 MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male