MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL SCREW KIT 2 HUMERAL SCREWS; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient had a nerve injury that was pre-existing, but it worsened after the initial left elbow procedure.Subsequently, the patient underwent a nerve grafting and nerve repair surgery to address the issue.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01206, 0001822565-2022-01209, 0001822565-2022-01210.Medical products: item#: 00840004410, humeral component plasma sprayed size 4 100 mm length for cemented use only; lot#: 64264426.Item#: 00840001407, ulnar component plasma sprayed size 4 75 mm length left for cemented use only; lot#: 64122609.Item#: 00840009400, articulation kit size 4 1 axle pin, 1 humeral bearing a, 2 ulnar bearings b sterile product do not resterilize; lot#: 64067854.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01206-1, 0001822565-2022-01209-1, 0001822565-2022-01210-1.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: HUMERAL SCREW KIT 2 HUMERAL SCREWS
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14220080
• Report Number: 0001822565-2022-01208
• Device Sequence Number: 5480522
• Product Code: JDC
• UDI-Device Identifier: 00889024271449
• UDI-Public: (01)00889024271449(17)290630(10)64459992
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K123862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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 Model Number: N/A
• Device Catalogue Number: 00840009000
• Device Lot Number: 64459992
• 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: 04/01/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 66 KG