MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS PROX BDY - LG 52MM; PROSTHESIS ELBOW

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(udi): n/a.Medical product: catalog #: 115370, comp rvs tray co 44mm, lot # 906990; catalog #: ep-115397, e1 44-41 std +3 hmrl brg, lot # 808390.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Will be returned.

Event Description

It was reported the patient was revised approximately 6 years ago.The patient came into clinic with pain and the x-ray showed the implant was broken in some way.Subsequently, the patient was revised about 2 weeks ago.

Event Description

The stem that was mentioned was actually the tray, the tray fracture surface that is stuck in the proximal body.The stem will not be reported on as there was no issue with it.

Manufacturer Narrative

The stem that was mentioned was actually the tray, the tray fracture surface that is stuck in the proximal body.The stem will not be reported on as there was no issue with it.

• Brand Name: COMPR SRS PROX BDY - LG 52MM
• Type of Device: PROSTHESIS ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10431369
• MDR Text Key: 203705283
• Report Number: 0001825034-2020-03219
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K111746
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 211219
• Device Lot Number: 760060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR