MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SHOULDER HUMERAL STEM GLOBAL

Catalog Number UNK SHOULDER HUMERAL STEM GLOB

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

Patient Problems Bone Fracture(s) (1870); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The literature article titled, "outcomes of an anatomic total shoulder arthroplasty with a contralateral reverse total shoulder arthroplasty" written by ryan m.Cox, bs, eric m.Padegimas, md, joseph a.Abboud, md, charles l.Getz, md, mark d.Lazarus, md, matthew l.Ramsey, md, gerald r.Williams jr, md, and john g.Horneff iii, md published by elsevier journal of shoulder and elbow surgery 2018 was reviewed.The article's purpose was to compare outcomes of patients with a tsa (total shoulder arthroplasty) verse rsa (reverse shoulder arthroplasty) in the contralateral shoulder.Data was initially compiled from 24 patients and filtered to a final 19 patients (9 in tsa group and 10 in rsa group) who received implants from 2004 to 2015.Depuy products and non depuy products were utilized in both tsa and rsa group.Depuy global ap system was listed among the tsa group and depuy delta xtend was listed among the rsa group.Cement manufacturer is not identified.Article reports 3 of the 5 patient excluded from initial data set required revision arthroplasty all in tsa group for periprosthetic infection (1), subscapularis rupture (1) and rotator cuff tear (1).In the final data set, complications were noted in each group captured in this complaint.Tsa group depuy products: global ap humeral stem, global ap humeral head, global ap glenoid.Rsa group depuy products: delta xtend humeral stem, delta xtend humeral cup, delta xtend glenosphere, delta xtend metaglene, delta xtend non locking screws (2), delta xtend locking screws (2).Total adverse events: infection (treated by revision) - tsa group.Subscapularis rupture (treated by revision) - tsa group.Rotator cuff tear (treated by revision) and one untreated (patient elected no revision surgery)- tsa group periprosthetic type b fracture (treated nonoperatively, no further information provided regarding anatomical location) - in tsa group.Acromial stress fracture 3 months post op (no further information regarding treatment) - in rsa group.Deep vein thrombosis (no further information regarding treatment) - in rsa group.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK SHOULDER HUMERAL STEM GLOBAL
• Type of Device: SHOULDER HUMERAL STEM
• 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: kara ditty-bovard ; 700 orthopaedic dr; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11178270
• MDR Text Key: 227054782
• Report Number: 1818910-2021-01270
• 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: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL STEM GLOB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention