MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN SHOULDER METAGLENE

Catalog Number UNK SHOULDER METAGLENE

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Not Applicable (3189)

Event Type  Injury  

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.

Event Description

Article reviewed, "longitudinal observational study of reverse total shoulder arthroplasty for irreparable rotator cuff dysfunction: results after 15 years", by christian gerber, md, et al., published in j shoulder elbow surg (2017).52 consecutive patients (23 men, 29 women) with an irreparable rotator cuff tear and secondary pseudoparalysis of active anterior elevation were treated with the delta iii prosthesis, (utilizing competitor cement if the humeral component was cemented).At the 15 year follow-up, 22 patients were alive/available for examination.One or more postoperative complications were recorded in 13 patients.This complaint addresses a patient who was subject to painful, aseptic loosening of the glenoid construct, at 2 months post-implantation, requiring revision-conversion to hemiarthroplasty.The specific details of the revision were not provided.

Manufacturer Narrative

Investigation summary: no device or product details were received.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 METAGLENE
• Type of Device: SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; depuy orthopaedics, inc. 18189; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7359756
• MDR Text Key: 103129701
• Report Number: 1818910-2018-55797
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

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: 03/13/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 10/03/2018
• Supplement Dates FDA Received: 10/05/2018
• 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