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

Catalog Number UNK SHOULDER GLENOID

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

Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 08/02/2017

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 ¿clinical and radiographic outcomes of the ream-and-run procedure for primary glenohumeral arthritis¿ written by jeremy s.Somerson, md, et al., published in the journal of bone and joint surgery, august 2, 2017, was reviewed.The purpose of the study was to answer the following two questions: (1) what factors were associated with the amount of medialization of the humeral head relative to the scapula after the ream-and-run procedure? (2) to what degree were the clinical outcomes after the ream-and-run procedure associated with the amount of postoperative medialization? the study analyzed 150 shoulders that had a ream-and-run shoulder arthroplasty between august 24, 2010 and october 22, 2013.The prosthesis used was the global advantage (depuy) and was secured using impaction autografting with bone harvested from the resected humeral head.132 patients (132 shoulders) consented to the study.Two-year clinical outcomes were available for 120 of these shoulders.Fourteen shoulders underwent subsequent procedures.Four patients underwent closed manipulation under anesthesia for persistent stiffness.Seven patients underwent single stage exchange of the humeral component and soft-tissue releases because of pain and stiffness; six of them had cultures positive for propionibacterium at the time of revision.Three patient had revision to total shoulder arthroplasty (one culture was positive for propionibacterium, and one revision was performed at an outside institution without culture data available).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9429314
• MDR Text Key: 185244125
• Report Number: 1818910-2019-118868
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOID
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention