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

Model Number N/A

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant product(d): unk nexel ulna catalog # ni lot # ni.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr repots were filled for this event: 0001822565 - 2017 - 06070.

Event Description

It was reported that patient underwent a total elbow replacement.Patient is scheduled for a revision surgery due to pain, multiple fractures around the implant, bone and nerve damage.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Concomitant medical products: 00840009500, nexel articulation kit size 5/6, 63063250.The 00840001507, nexel elbow ulnar component, 62897450.The 00111914001, palacos lvg 1x40 single, 79924395.The 00840108000, elbow torque driver, 56613797.The 00840009000, humeral screw kit 2 humeral screws, 63006357.The 32810503800, cement restrictor with nozzle 1 - 16 mm diameter 1 - 25 mm diameter, 63064916.The 00504905300, disposable bone cement curette, 62971147.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-06070, 0001822565-2017-06659.

Event Description

It was reported that the patient underwent a total elbow replacement.Subsequently, the patient has been indicated for a revision surgery due to severe pain and spontaneous, non-trauma-induced fractures of the humerus and ulna around the implanted components.The indicated revision procedure may also involve amputation due to bone and nerve damage.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.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.

• Brand Name: NEXEL ELBOW HUMERAL COMPONENT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6816868
• MDR Text Key: 83501911
• Report Number: 0001822565-2017-06039
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• 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: 00840004610
• Device Lot Number: 62903325
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR