MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE HUMERAL ASSEMBLY SMALL 8 INCH LENGTH FOR CEMENTED USE ONLY; PROSTHESIS, EXTREMITIES

Catalog Number	32810502508
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Loss of Range of Motion (2032)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item# 00112114001; lot# 19aa18160; item# 32810503506; lot# 63873781; item# 32810502504; lot# 64410229.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 remains implanted.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 a patient underwent a revision surgery approximately one (1) year and four (4) months ago 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.The legal allegations noted that the patient continues to experience near total loss of right arm function and paralysis.No further interventions have been reported to date.To date, it is not confirmed that a zimmer biomet cement was used during this revision surgery.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
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 (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.Legal document - the consequences of this intervention [revision] were disastrous.[patient] is very handicapped, and today very embarrassed by this complication of orthopedic surgery on the right side, since he now presents almost total paralysis of the upper right limb¿has almost lost the use of his right arm.No further interventions have been reported.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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 SMALL 8 INCH LENGTH FOR CEMENTED USE ONLY
• 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: 12737507
• Report Number: 0001822565-2021-03158
• Device Sequence Number: 19875157
• Product Code: JDC
• UDI-Device Identifier: 00889024273955
• UDI-Public: (01)00889024273955(17)231231(10)64122452
• 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
• 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): 12/14/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 32810502508
• Device Lot Number: 64122452
• 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: 12/13/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2018
• 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: Disability; Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 124 KG