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

Catalog Number UNK SHOULDER HUMERAL STEM

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/01/2003

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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 ¿humeral fixation by press-fitting of a tapered metaphyseal stem¿, written by frederick a.Matsen iii, md et all; published in the journal of bone and joint surgery, volume 85-a, number 2; february 2003; was reviewed.The purpose of the article was for the authors to test their hypothesis that the press-fit humeral stem, designed to respect the taper of the proximal humeral canal, would be associated with a low rate of loosening in patients managed with primary arthroplasty for glenohumeral osteoarthritis.The press-fit prosthesis used in the study was a press-fit humeral component, global (depuy).It was implanted in 131 patients without cement.The surgeries were performed by 10 surgeons with a minimum of two-year follow-up.Four patients were excluded due to the radiographs being deemed inadequate, leaving 127 patients for review.No component showed subsidence or a shift in position.50 of the 127 shoulders that had suitable radiographs, had no radiolucency.Of the 77 shoulders that had some radiolucency, two had radiolucency in the proximal four zones and 75 had radiolucency only at the distal tip.Only eleven radiolucent lines were greater thank one mm in width.A neutral stem orientation was significantly less likely to be associated with radiolucency.The rate of radiolucent lines was not different between patients who had a hemiarthroplasty and a total shoulder arthroplasty.During the first four postoperative years, the duration of follow-up did not influence the radiolucency rate; the radiolucency rate was 60% among patients who had been followed for at least 24 months, 69% among those who had been followed for at least 36 months, and 50% who had been followed for at least thirty-six months, and 50% for those who had been followed for at least 48 months.

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.H10 additional narrative: corrected: h6(device code and closure codes).Product complaint (b)(4).Investigation summary: the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up 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: 9410085
• MDR Text Key: 220254581
• Report Number: 1818910-2019-118605
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• 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: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1