MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLBL UNITE ANT BODY 135 SZ 10; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Catalog Number 110030000

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Unspecified Tissue Injury (4559)

Event Date 11/03/2023

Event Type  Injury  

Event 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.

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.

• Brand Name: GLBL UNITE ANT BODY 135 SZ 10
• Type of Device: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• 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: 18138709
• MDR Text Key: 328117614
• Report Number: 1818910-2023-23180
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004356
• UDI-Public: 10603295004356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170748
• 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
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 110030000
• Device Lot Number: 8733370006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/15/2023
• 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: GLOBAL UNITE HEAD 56X18 ECC
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 85 KG