MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE ONLY SMALL LONG FLANGE; PROSTHESIS, EXTREMITIES

Catalog Number	32810503506
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyporesponsive to stimuli (2683); Peripheral Nervous Injury (4414)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-03157.Concomitant products: item# 32810502504; lot# 64410229.Item# 32810502508; lot# unk.Item# unk cerclage wire; lot# unk.Item# unk cerclage wire; lot# unk.Report source: foreign - event occurred in (b)(6).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 or Problem Description
It was reported that an initial right total elbow arthroplasty was performed approximately one (1) year and five (5) months ago.During the initial procedure, it was noted that after trialing, non-zb cement was placed into the humeral and ulnar cavities for final implants.However, the cement hardened too quickly, making it impossible to place the intended implants.Upon removing the hardened cement from the humerus, the external condyle of the humerus fractured.The fracture was reduced with two cerclage wires and an alternative humeral component was cemented into place.Nine (9) days later the patient returned for revision of the elbow due to unknown mechanical complications and a radial nerve deficit resulting in loss of sensation and motor function.During the revision, a plate was applied to the humeral fracture site, and a new humeral component was cemented into place.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial procedure on (b)(6) 2020 findings: previous screw and humeral implant and cement removed without difficulty, neurolysis of the ulnar and radial nerve performed, new cm implants placed, full extension to 100 degrees flexion, osteosynthesis on the internal condyle with a alps external plate, no intraop complications, immobilize in extension for 15 days.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE ONLY SMALL LONG FLANGE
• Common Device Name: 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: 12737512
• Report Number: 0001822565-2021-03156
• Device Sequence Number: 17185027
• Product Code: JDC
• UDI-Device Identifier: 00889024274044
• UDI-Public: (01)00889024274044(17)230131(10)63873781
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 32810503506
• Device Lot Number: 63873781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 124 KG