MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK HUMERUS; PROSTHESIS, EXTREMITIES

Catalog Number EXT-C/M ELBOW-HUMERUS-UNK

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign - event occurred in (b)(6).Literature title - outcomes of semiconstrained total elbow arthroplasty performed for arthritis in patients under 55 years old multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01945.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Event Description

Approximately three (3) weeks ago, a journal article was retrieved from journal of shoulder and elbow surgery (2019) that reported a retrospective, single-center study from france from 1998 to 2008 that looked at outcomes of semiconstrained total elbow arthroplasty (tea) for patients with arthritis under 55 years old.The purpose of the study was to investigate the mid-term survivorship of primary tea in patients who underwent a linked semiconstrained arthroplasty before 55 years of age.The study reported one patient underwent a left bipolar elbow revision due to aseptic loosening 5.5 years post-operatively.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause was unable to 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.

Event Description

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

• Brand Name: UNK HUMERUS
• Type of Device: PROSTHESIS, EXTREMITIES
• 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: 10111011
• MDR Text Key: 194618371
• Report Number: 0001822565-2020-01946
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EXT-C/M ELBOW-HUMERUS-UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2020
• 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: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention