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 Problem Muscular Rigidity (1968)

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

"three or four parts complex proximal humerus fractures: hemiarthroplasty versus reverse prosthesis: a comparative study of 40 cases." was read for mdr reportability.After review of the article for mdr reportability, the article indicates a delta iii shoulder was implanted in 19 shoulders between 1991 to 2004.No patient identifies were provided for the 19 patients.Below are the findings from the article: one patient suffered sympathetic dystrophy and recovered with medical treatment.

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.Product complaint #: (b)(4).Investigation summary: no device associated with this report was 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 will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER METAGLENE
• Type of Device: SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8272322
• MDR Text Key: 133911480
• Report Number: 1818910-2019-82042
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• 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
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention