MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE HEAD 44X15 STD; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Model Number	1100-44-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was a primary surgery performed on (b)(6) 2019.After surgery, it was confirmed that greater tubercle was atrophied.Therefore, the implants will be removed, and rsa will be performed by other company¿s product.The revision surgery date is (b)(6) 2023.During the primary surgery implant insertion, a crack was confirmed in the greater tubercle.The surgeon commented that the crack was a possible cause other than the products.No further information is available.
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 HEAD 44X15 STD
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16796873
• Report Number: 1818910-2023-08542
• Device Sequence Number: 11548071
• Product Code: HSD
• UDI-Device Identifier: 10603295004516
• UDI-Public: 10603295004516
• 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: 2019
• Device Explanted 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): 04/24/2023

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: 1100-44-500
• Device Catalogue Number: 110044500
• Device Lot Number: HN2632
• 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: 04/10/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• 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: GL UNITE ANT BDY 135 SZ 06 08; GLOBAL UNITE STD STEM SZ 8
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female