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

Catalog Number UNK SHOULDER HUMERAL HEAD

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

Patient Problems Muscular Rigidity (1968); Tissue Damage (2104); No Code Available (3191)

Event Date 07/05/2017

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, "does postoperative glenoid retroversion affect the 2-year clinical and radiographic outcomes for total shoulder arthroplasty" written by benjamin c.Service, md, jason e.Hsu, md, jeremy s.Somerson, md, stacy m.Russ ba, and frederick a.Matsen iii md published online 5 july 2017 was reviewed.The article's purpose was to discover if glenoid components implanted in 15 degrees or greater retroversion had less improvement in the simple shoulder test (sst) score and lower sst scores; if higher percentages of central peg lucency, higher lazarus radiolucency grades, higher mean percentages of posterior decentering, and more frequent central peg perforation; or if a greater percentage having revision for glenoid component failure compared with patients with glenoid components implanted in less than 15 degrees retroversion.Data was compiled from 71 patients age mean of 68 years and follow up mean of 2.5 years.All implants were depuy but cement manufacturer is not identified.Figueres 6-9 provide radiographic imaging for illustrative purposes of measurements.Depuy products: global advantage system adverse events: revision for 'stiffness" (humeral head exchange 3.5 months post index procedure) revision for subscapularis reconstruction with allograft tendon ("after traumatic failure occurring 25 months after the index operation") - no further details provided revision for subscapularis repair and exchange of humeral components (article reports caused by fall approx 2 months post index operation).

Manufacturer Narrative

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.  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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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 HEADS
• Type of Device: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9962131
• MDR Text Key: 187708381
• Report Number: 1818910-2020-10778
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention