MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE HEAD 56X18 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Catalog Number	110056610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Unspecified Tissue Injury (4559)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Patient was revised due to pain.Patient had his left shoulder replaced sometime ago, the exact date is unknown at this time.Patient did well initially, over the last year, the patient lost range of motion, and experience, pain and discomfort.Surgeon stated the patient had a repairable rotator cuff tear, and that he would need to convert the anatomic construct to a reverse construct.The anatomic proximal body was explanted along with a humeral head, and anatomic glenoid.The humeral sam was left in situ.A reverse, proximal body, humeral club warren planted onto the stem, a reverse base plate, with a glenosphere was implanted into the glenoid for a reverse shoulder construct.Lot numbers for the anatomic and glenoid and humeral stem were unable to be recorded.There was no surgical delay as a result of products.Activity level - yes.Doi: unknown.Dor: (b)(6) 2023.Affected side: left shoulder.

• Brand Name: GLOBAL UNITE HEAD 56X18 ECC
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 18138707
• Report Number: 1818910-2023-23179
• Device Sequence Number: 20472998
• Product Code: HSD
• UDI-Device Identifier: 10603295004776
• UDI-Public: 10603295004776
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2023

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 Catalogue Number: 110056610
• Device Lot Number: 732553
• 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: 11/03/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 85 KG