MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH FOR CEMENTED USE ONLY; ELBOW, PROSTHESIS

Model Number	00-8400-044-10
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Osteopenia/ Osteoporosis (2651)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Ulnar component plasma sprayed size 4 75 mm length right cat: 00840002407 lot: 63480682.Humeral screw kit 2 humeral screws cat: 00840009000 lot: 63610436.Articulation kit size 4 1 axle pin, 1 humeral bearing a, 2 ulnar bearings b sterile product do not resterilize cat: 00840009400 lot: 63419001.Foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.
Event or Problem Description
It was reported that the patient underwent to right total elbow arthroplasty.Subsequently, the patient is experiencing severe pain, discomfort and unable to lift arm.The radiographic assessment revealed an ulnar component loosening at the six and nine month follow ups.The radiographic assessment further revealed a humeral loosening at the nine month follow up.Progression of loosening with risk of periprosthetic fracture reported during 3-year follow up for both humeral and ulnar components.A revision procedure has been indicated but not yet scheduled.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a hinged right elbow arthroplasty is present.There is extensive osteolysis along both the humeral and ulnar implants with implant loosening and displacement.The humeral implant extends through the humeral diaphysis and there is borderline extrusion of the ulnar implant through the ulnar diaphysis.Bone quality is markedly osteopenic.No displaced fracture is present.There is extra-osseous radio-opaque cement.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH FOR CEMENTED USE ONLY
• Common Device Name: ELBOW, PROSTHESIS
• 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: 14237536
• Report Number: 0001822565-2022-01243
• Device Sequence Number: 19944942
• Product Code: JDC
• UDI-Device Identifier: 00889024271340
• UDI-Public: (01)00889024271340(17)260430(10)63313336
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 00-8400-044-10
• Device Catalogue Number: 00840004410
• Device Lot Number: 63313336
• 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: 07/20/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 52 KG