MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK C-M HUMERAL COMPONENT; PROSTHESIS, ELBOW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ossification (1428)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01916.

Event Description

In a journal article published approximately one year ago, studying total elbow arthroplasty survivorship for arthritic patients under 55 years old, it was reported that 1 of 19 patients was noted to have heterotopic ossification and underwent ossification excision.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Siala, m.Et al.Outcomes of semiconstrained total elbow arthroplasty performed for arthritis in patients under 55 years old.Journal of shoulder and elbow surgery.2019: 1-8.This follow-up is being submitted to relay additional information.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.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.(b)(4).

Event Description

No further event information available at the time of this report.

• Brand Name: UNK C-M HUMERAL COMPONENT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10100767
• MDR Text Key: 195167519
• Report Number: 0001822565-2020-01892
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK C-M ULNA COMPONENT CAT#NI LOT#NI.
• Patient Outcome(s): Hospitalization; Required Intervention