MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ELBOW IMPLANT

Catalog Number UNK ELBOW

Device Problem Loss of Osseointegration (2408)

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

Event Date 04/20/2020

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.

Event Description

The patient was revised to address cancer, infection and loosening of the ulnar component at the bone to implant interface.Unknown cement was used.The patient has had multiple elbow surgeries due to cancer.Doi: (b)(6) 2008.Dor: (b)(6) 2020.Right elbow.

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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 ELBOW IMPLANT
• Type of Device: ELBOW IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10017399
• MDR Text Key: 189609220
• Report Number: 1818910-2020-11584
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ELBOW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN ELBOW HUMERAL YOKE; UNKNOWN ELBOW IMPLANT; UNKNOWN ELBOW IMPLANT; UNKNOWN ELBOW HUMERAL YOKE; UNKNOWN ELBOW IMPLANT; UNKNOWN ELBOW IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 151