MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL STEMS

Catalog Number UNK SHOULDER HUMERAL STEM

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems Calcium Deposits/Calcification (1758); Bone Fracture(s) (1870); No Code Available (3191)

Event Date 09/01/2018

Event Type  malfunction  

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 entitled ¿short-term results of the depuy global unite platform shoulder system: a two-year outcome study¿ written by joseph a.Abboud et al, published in the archives of bone and joint surgery, volume 6, number 5, september 2018; was reviewed.The purpose of the study within the article was to examine the short-term functional outcomes, radiographic results, and revision rates of patients treated with the global unite platform shoulder system.Both primary and revision arthroplasty patients were followed for a minimum of two years from their surgery.Anatomic and reverse arthroplasty patients were included in the study.There were 55 primary anatomic shoulder arthroplasties and 37 primary reverse shoulder arthroplasties (delta xtend, using the global unite humeral stem).There were two revision procedures to an anatomic total shoulder arthroplasty and three revision procedures to a reverse shoulder arthroplasty.For the primary anatomic total shoulder arthroplasties, there were 38 cases that utilized a standard anchor peg glenoid, depuy; 15 cases that utilized a steptech anchor peg glenoid (depuy) and two cases using a non-depuy glenoid.Stem position was neutral in 32 patients, valgus in one, and varus in nine.At one-year follow-up, there were four radiographs with proximal migration of the humerus, one with mild lesser tuberosity fragmentation, and one with calcification of the long-head of the triceps.At two-year follow-up, postoperative radiographs were available for 16 patients.Stem position was neutral in 12 patients and varus in four.There was one radiograph of proximal migration of the humerus, one with medial dislocation of the humerus, and two with calcification of the long-head of the triceps.For the primary reverse total shoulder arthroplasties, the delta xtend was used with a global unite humeral stem (both depuy).At one-year postoperative radiographs were available for 30 patients.There were four cases of scapular notching.Stem position was neutral in 26 patients, valgus in two, and varus in two.Radiographic data showed one subject with a humeral shaft fracture, one subject with a medial dislocation of the humerus, and seven with calcification of the long-head of the triceps.At two-year follow-up, postoperative radiographs were available for 12 patients.There were three cases of scapular notching.Stem position was neutral in 11 patients and varus in one patient.There were five radiographs with calcification of the long-head of the triceps.There were two cases in which anatomic components were placed as a revision procedure.One case was for a painful total shoulder arthroplasty and the subject underwent a humeral revision due to stem malposition with maintenance of the well-fixed glenoid component.The second case was placement of an anatomic total shoulder arthroplasty from a painful hemiarthroplasty cement spacer.The spacer had been placed for management of a prior infected humeral resurfacing implant.There was no radiographic data available at two-years.It was also not specified who the manufacturers of the original implants.There were also three cases in which reverse components were used for revision.Two cases were conversions from a prior hemiarthroplasty, while one case was a revision from a prior hemiarthroplasty, placed for fracture, now with a rotator cuff tear and glenoid arthrosis.Two-year radiographic data were available for two patients showing scapular notching in one patient.Stem positioning was neutral in one patient and valgus in the other.Both patients were found to have calcification of the long-head of the triceps.It was also not noted who the manufacturer was of the original implants in these revisions." this complaint will capture the reverse tsa's.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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 : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER HUMERAL STEMS
• Type of Device: SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9506423
• MDR Text Key: 188321621
• Report Number: 1818910-2019-124518
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention