MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER GLENOID

Catalog Number UNK SHOULDER GLENOID

Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Synovitis (2094); Joint Dislocation (2374); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 03/26/2017

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, "exploring failure of total shoulder arthroplasty systems through implant retrieval, radiographic, and clinical data analyses" written by drew d.Moore, md, james e.Moravek, md, erin a.Baker, phd, meagan r.Salsibury, ms, kevin c.Baker, phd and j.Michael wiater, md published by the journal of shoulder and elbow arthroplasty accepted by publisher on 26 march 2017 was reviewed.The article's purpose to explore relationships and document observations of damage modes on retrieved metallic and polyethylene tsa components, radiographic analysis, intraoperative observations, patient factors, and implant design characteristics, in order to derive additional information regarding potential causes of in vivo implant damage and clinical failure of tsa.Data was compiled from obtained implants that were retrieved between 2000 and 2012 from 48 patients.Retrieved implants included depuy and non-depuy implants.The article does not identify cement manufacturer.Figure 1 provides photographic images for illustrative purposes of material level damages on various implants and figure 2c provides a radiographic image for illustrative purposes of zones.Depuy products utilized: global/global advantage shoulder system with poly glenoid as all implants were retrieved the following is listed revision reasons: pain glenoid loosening rotator cuff tear infection humeral loosening osteolysis bony fracture (anatomical location not provided) fractured glenoid component dislocation impingement intraoperative findings of synovitis intraoperative findings of wear debris.

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.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 GLENOID
• Type of Device: SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9962382
• MDR Text Key: 188342607
• Report Number: 1818910-2020-10783
• 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOID
• 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