MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH LEFT; PROSTHESIS, ELBOW

Catalog Number	00840001407
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032)
Date of Event	08/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision of the left elbow due to loosening of the ulna component and loss of flexion or extension.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).D10: cat: 00840004415, lot: 64916243, humeral component plasma sprayed size 4, 150 mm length.For cemented use only.Cat: 00840009400, lot: 65064304, articulation kit size 4, 1 axle pin, 1 humeral bearing a, 2 ulnar bearings, b sterile.Product do not resterilize.Cat: 00840009000 lot: 65471795 humeral screw kit 2 humeral screws.G2: foreign-australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02211, 0001822565-2023-02212.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Mechanical (g04) - stem.Reported event was confirmed by review of radiographs.Review of the available records identified the following:  a left elbow arthroplasty is intact.There is extensive radiolucency along the ulnar implant reflecting osteolysis and implant loosening.Bone quality is markedly osteopenic. anterior, medial, and lateral heterotopic ossification is noted and there is extensive vascular calcification.Device history record (dhr) was reviewed and no discrepancies were found.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.

• Brand Name: ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH LEFT
• Common Device Name: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• 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: 17596393
• Report Number: 0001822565-2023-02210
• Device Sequence Number: 7421578
• Product Code: JDC
• UDI-Device Identifier: 00889024271227
• UDI-Public: (01)00889024271227(17)300816(10)64590931
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 12/19/2023

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 Catalogue Number: 00840001407
• Device Lot Number: 64590931
• 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: 08/05/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male