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

Model Number	00-8400-044-10
Medical Device Problem Codes	Use of Device Problem (1670); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign: (b)(6).Concomitant medical devices: humeral screw kit 2 humeral screws cat: 00840009000 lot: 63531647; articulation kit size 4 1 axle pin, 1 humeral bearing a, 2 ulnar bearings b sterile product cat: 00840009400 lot: 63344249; ulnar component plasma sprayed size 4 75 mm length left cat: 00840001407 lot: 63485949.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 a revision procedure due to loosening and infection.The patient underwent a two stage revision procedure.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified, the humeral and ulna contain bone cement.Nicks and gouges are seen on the ulna.Radiographs were provided and noted loosening of the components.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined regarding implant loosening.A summary of the investigation has been sent to the complainant.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: HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH
• 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: 12883031
• Report Number: 0001822565-2021-03407
• Device Sequence Number: 14440063
• Product Code: JDC
• UDI-Device Identifier: 00889024271340
• UDI-Public: (01)00889024271340(17)260731(10)63406767
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• 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): 03/23/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 00-8400-044-10
• Device Catalogue Number: 00840004410
• Device Lot Number: 63406767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/03/2021
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 64 KG