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

Catalog Number UNK SHOULDER GLENOID

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

Patient Problems Hematoma (1884); Tissue Damage (2104); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 01/01/2016

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 ¿a prospective functional outcome study of shoulder arthroplasty for arthritis with an intact rotator cuff¿, written by robert m.Orfaly, md, frcs, et al.; published in the journal of shoulder and elbow surgery, may/june 2013; was reviewed.The purpose of the article was to report on prospective pain relief and functional outcome data on 65 shoulder arthroplasties in 55 patients.37 total shoulder arthroplasties and 28 hemiarthroplasties were followed up for a mean of 4.3 years (2-8 years).Two main issues are addressed; assessing the benefits of shoulder arthroplasty quantitatively; and to explore the role of glenoid replacement.The implant used was the global total shoulder arthroplasty system (depuy).Keeled glenoids were used in 31 shoulders and pegged glenoids were used in 31 shoulders based on surgeon preference.All patients had improvement scores after surgery.There were no cases of definite component loosening based on serial radiographs and no cases of heterotopic bone formation were noted.Three complications were noted in the series: one patient developed a hematoma and a detachment of the subscapularis tendon in the early postoperative period.Evacuation of the hematoma and repair of the subscapularis were performed.There were no further sequelae.Another patient developed a separation of the anterior deltoid origin after a traumatic event one year after surgery.An open repair was performed, and the patient was functioning well with a strong deltoid at final follow-up.There was one case of symptomatic glenoid loosening 7 years after the index procedure.The patient was treated with allograft placed in the glenoid defect.The patient has done well, with one year of follow-up from the revision.

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.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER GLENOID
• Type of Device: UNK SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9410692
• MDR Text Key: 185179701
• Report Number: 1818910-2019-118737
• 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?: 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: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention