MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK DISCOVERY ELBOW PROSTHESIS, ELBOW

Catalog Number UNK DISCOVERY ELBOW

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Reported event was unable to be confirmed as part number and lot number of the device involved in the incident is unknown. Device history record review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. This report is being submitted late as it has been identified in remediation. Large, r. , tambe, a. , cresswell, t. , espag, m. , & clark, d. I. (2014). Medium-term clinical results of a linked total elbow replacement system. Bone & joint journal, 96-b(10), 1359-1365. Doi:10. 1302/0301-620x. 96b10. 33815.

Event Description

Information was received based on review of a journal article titled, "medium-term clinical results of a linked total elbow replacement system". It was reported that one patient underwent a repair and debridement of olecranon bursitis at an unknown date. There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNK DISCOVERY ELBOW
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7112993
• MDR Text Key: 94728236
• Report Number: 0001825034-2017-11122
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK DISCOVERY ELBOW
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/09/2014
• 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
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 12/13/2017 Patient Sequence Number: 1