MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE STD STEM SZ 10; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	1100-10-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	05/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was a tsa performed on (b)(6) 2023.The surgery was completed successfully without any surgical delay.On (b)(6) 2023, the patient complained of pain.On (b)(6) 2023, it was confirmed that the greater tubercle was displaced around the top of the head.Therefore, the surgeon decided to perform revision surgery instead of preservation.On (b)(6) 2023, a revision surgery was performed.The surgeon assumed the worst and started the surgery with the possibility of replacing rsa.Only the body and head were replaced.It was locked with soft anchor.A burr hole was created in shaft.Permatepe and dynatape were placed over the rotator cuff and inserted into the burr hole, holding the greater tubercle, in placed and locked.According to the surgeon, other possible causes besides the products are the angle of the posterior twist and the greater tubercle injury during the retractor operation.No further information is available.Doi: (b)(6) 2023; doe: (b)(6) 2023; affected side: unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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.

• Brand Name: GLOBAL UNITE STD STEM SZ 10
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17117785
• Report Number: 1818910-2023-12203
• Device Sequence Number: 15115665
• Product Code: HSD
• UDI-Device Identifier: 10603295004080
• UDI-Public: 10603295004080
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: 1100-10-100
• Device Catalogue Number: 110010100
• Device Lot Number: 4002526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GLBL UNITE ANT BODY 135 SZ 10; GLOBAL UNITE HEAD 40X15 ECC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female