MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXEL ARTICULATION KIT; PROSTHESIS, ELBOW

Model Number N/A

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

Patient Problems Inflammation (1932); Synovitis (2094)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Associated products : unknown nexel humeral screw kit.Unknown nexel humeral component.Unknown nexel tea ulnar component.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.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 -2020-02335.0001822565 -2020-02337.0001822565 -2020-02338.

Event Description

It was reported the patient underwent a second revision as the ulnar component was loose proximally and patient was experiencing synovitis.All devices were explanted.Cultures came back negative for infection; however, surgeon elected to treat patient with antibiotics and underwent a two stage revision surgery, where the spacer was removed approximately three months later and implanted with additional zimmer biomet devices.

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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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 report 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: UNKNOWN NEXEL ARTICULATION KIT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10217280
• MDR Text Key: 197338018
• Report Number: 0001822565-2020-02336
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 10/07/2020
• 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: 55 YR