MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 UNKNOWN SHOULDER HUMERAL STEMS

Catalog Number UNK SHOULDER HUMERAL STEM

Device Problems Loss of or Failure to Bond (1068); 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 11/01/2018

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.(b)(4).

Event Description

The literature article entitled ¿the midterm results of the delta xtend reverse shoulder system: a five-year outcome study¿ written by john g.Horneff et al; printed in the archives of bone and joint surgery, volume 6, number 6, printed in november 2018, was reviewed.The goal of the study was to examine the midterm functional outcomes, radiographic results, and revision rates of patients treated with the delta xtend reverse shoulder system.Both primary and revision arthroplasty patients were followed at a minimum of five years out from their surgery.The depuy products used: the delta extend reverse shoulder system which includes, a humeral stem, epiphysis, cup, metaglene, glenosphere and at least two locking screws.50 of 198 patients who went rtsa between january 2008 and december 2011 were available for follow-up at least five years postoperatively.The study reports 17 revisions with an average of 5.9 years from initial operation.Many of the preoperative radiographic meausres used for the primary cases were unable to be evaluated in the revision cases due to the nature of the cases being revisions of prior arthroplasties.Only four cases could be evaluated using the favard and hamada classification.The preoperative favard group classification for those four cases were two favard group a and two favard group c.The preoperative classification for hamada classification were two at grade 2 and two at grade 5.Sirveaux classification for the nine cases with appropriate radiographs was: nine at e10, one at e1, four at e2, and three at e3.The available five-year outcome data for the 50 patients varied significantly due to constraints in patient willingness to participate in five-year follow-up and the logistics of being evaluated, some outcome scores were unavailable for patients.Adverse events and/or findings are detailed below.Postoperative radiographs were available for 92% of patients (46/50).Scapular notching was also assessed on the five-year postoperative radiographs.For all patients, the breakdown of sirveaux scapular notching was: 65.2% (30/46) at grade 0; 23.9% (11/46) at grade 1; 10.9% (5/46) at grade 2.For primary patients, the breakdown of sirveaux scapular notching was: 65.6% (21/32) at grade 0; 25% (8/32) at grade 1; 9.4% (3/32) at grade 2.Lastly, for revision cases, the breakdown of sirveaux scapular notching was: 64.3% (9/14) at grade 0; 21.4% (3/14) at grade 1; 14.3% (2/14) at grade 2.Postoperative radiographs were also evaluated for stem positioning.Overall, 69.6% (32/46) of stems were in neutral position, 21.7% (10/46) were in valgus position, and 8.7% (4/46) were in varus position.For primary patients, 71.9% (23/32) were in neutral position, 25% (8/32) were in valgus position, and 3.1% (1/32) were in varus position.For revision patients, 64.3% (9/14) were in neutral position, 14.2% (9/14) were in valgus position, and 21.4% (2/14) were in varus position.There was no significant correlation between stem position and scapular notching.Two patients demonstrated loosening of the humeral stem on radiographs.Both were revision patients.One patient sustained a periprosthetic fracture distal to the humeral stem and was treated successfully with a sarmiento brace.Nine patients demonstrated calcification of the long head of the triceps tendon.This was the most common radiographic finding.

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.H10 additional narrative: corrected:h6(device codes).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 FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• MDR Report Key: 9547952
• MDR Text Key: 185755071
• Report Number: 1818910-2020-00469
• Device Sequence Number: 1
• Product Code: KWS
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• 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: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention