MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PROSTHESIS, ELBOW

Catalog Number 00840004510

Device Problem No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Peroneal Nerve Palsy (2362); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Multiple mdr's were reported for this event. Please also see associated reports: 0001822565 - 2019 - 01609, 0001822565 - 2019 - 01608, 0001822565 - 2019 - 01607, 0001822565 - 2019 - 01604. Primary di# (b)(4). Concomitant medical products: part number lot code description, 00840004510 63287679 humeral stem, 00840009000 63610435 humeral screw, 00840001507 63175486 ulnar component, 00840009500 63570105 articulation kit. Report source: (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device remains implanted.

Event Description

It was reported the patient experienced severe pain and disability secondary to post operative radial nerve palsy. The event was reportedly not device related, but related to the surgical procedure. No further information is available at this time.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. No device was returned; the complaint cannot be confirmed. Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified. Root cause is unknown. 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.

• Brand Name: HUMERAL COMPONENT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8523569
• Report Number: 0001822565-2019-01604
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 00840004510
• Device Lot Number: 63287679
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Age: 42 YR
• Patient Weight: 73
• Patient Outcome(s): Other