MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SHOULDER GLENOID GLOBAL APG+

Catalog Number UNK SHOULDER GLENOID GLOBAL AP

Device Problem Migration (4003)

Patient Problem Osteolysis (2377)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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

"this complaint is from a literature source.Literature citation: ricchetti et, jun bj, jin y, ho jc, patterson te, dalton je, derwin ka, iannotti jp.Relationship between glenoid component shift and osteolysis after anatomic total shoulder arthroplasty: three-dimensional computed tomography analysis.J bone joint surg am.2021 aug 4;103(15):1417-1430.Doi: 10.2106/jbjs.20.00833.Pmid: 33835109; pmcid: pmc8360268.Objective/methods/study data: in a series of 152 patients (42 walch a1, 16 a2, 7 b1, 49 b2, 29 b3, 3 c1, 3 c2, and 3 d glenoids) undergoing anatomic tsa with a polyethylene glenoid component, sequential 3d ct analysis was performed preoperatively (ct1), early postoperatively (ct2), and at a minimum 2-year follow-up (ct3).Glenoid component shift was defined as a change in component version or inclination of +-3 from ct2 to ct3.Glenoid component central anchor peg osteolysis (cpo) was assessed at ct3.Factors associated with glenoid component shift and cpo were evaluated by the authors.All glenoid components are noted to be depuy apg/steptech.The article does not discuss revisions for the findings and notes that cement is utilized in the peripheral pegs while the central peg is cementless.Cement manufacturer is not identified.Adverse event(s) and provided interventions for depuy apg/steptech glenoid: qty 78 shifting (greater than 3 degrees) of the glenoid component detected via ct scan - no treatment provided.Qty 19 patients with osteolysis noted around central peg (cpo) - no treatment provided.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK SHOULDER GLENOID GLOBAL APG+
• Type of Device: SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 15074876
• MDR Text Key: 304720588
• Report Number: 1818910-2022-13643
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOID GLOBAL AP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• 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