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

Catalog Number UNK SHOULDER METAGLENE

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

Patient Problems Unspecified Infection (1930); Not Applicable (3189); No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.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 will be filed as appropriate.

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 ¿long-term results of the delta xtend reverse shoulder prosthesis¿ written by david bassens, md, et al.Published in the journal of shoulder and elbow surgery in 2018, was reviewed.The purpose of this single-center study was to describe the clinical results of the delta xtend reverse prosthesis, which was introduced in 2006, with a minimum follow-up of eight years.The depuy products used: the delta extend reverse shoulder system which includes, a humeral stem, epiphysis, cup, metaglene, glenosphere and at least two locking screws.Between october 2006 and december 2009, 149 rsa¿s were performed.23 were excluded because they were revision cases of a shoulder arthroplasty; 38 patients died due to unrelated causes and were excluded (though there were no arguments to assume that there had been a problem with the prosthesis; and 12 patients were lost to follow-up.Of the remaining 76 patients, two needed early revision for infection or dislocation of the primary prosthesis.No other complications requiring new surgery were seen in this group.74 patients were monitored for at least eight years after primary rsa.Of the 74, 34 were seen in the outpatient clinic at least eight years after surgery; the other 40 patients were contacted by telephone, and a patient-based score was obtained.A comparison of the clinician-based scores with the patient-based scores did not show a significant decrease.Follow-up was conducted at three months, six months, one year, two years, five years and latest follow up (at least eight years).The rate of revision surgery was 2.6%, making the survival rate 97.4% after eight years.

• Brand Name: UNKNOWN SHOULDER METAGLENE
• Type of Device: SHOULDER METAGLENE
• 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 ; 6107428552
• MDR Report Key: 9575584
• MDR Text Key: 186230913
• Report Number: 1818910-2020-01464
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

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 METAGLENE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention