MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 5/6 1 AXLE PIN, 1 HUMERAL BEARING A, 2 ULNAR BEARINGS B; ELBOW, PROSTHESIS

Catalog Number	00840009500
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Radiolucent Lines (4848)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03069.D10: ulnar component plasma sprayed size 5 75 mm length right cat: 00840002507, lot: 64662268.G2: foreign: finland.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.
Event or Problem Description
It was reported that the patient was revised due to component loosening and poly wear approximately two years and seven months post implantation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial right elbow fracture with right elbow arthroplasty.Initial anatomic alignment without abnormality.Subsequent images demonstrate progressive osteolysis along the ulnar and to a lesser degree humeral implants with suspected ulnar implant loosening as noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: 2 year follow-up ¿ moderate pain ¿ rom > 100 degrees and stable ¿ radiolucency noted in areas 28-36 of lateral view, and areas 10-18 on ap view ¿ ulnar osteolysis found to be present to the distal, medial, and proximal aspects ¿ suspected/presumable aseptic ulnar component loosening, revision ¿ no further details regarding reoperation available currently ¿ operation position of the implants were evaluated good, but there was minimal poly wear (the edge of the plastic was rounded) on medial side.The ulnar component was loose.No metallosis existed.Five tissue samples were negative in bacterial culture, but synovial fluid cells were 5000, of which 88% were neutrophils.But the patient suffer from rheumatoid arthritis.I interpreted the case an aseptic loosening.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.The reported event is confirmed as x-ray was provided.

• Brand Name: ARTICULATION KIT SIZE 5/6 1 AXLE PIN, 1 HUMERAL BEARING A, 2 ULNAR BEARINGS B
• Common Device Name: ELBOW, PROSTHESIS
• 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: 18136852
• Report Number: 0001822565-2023-03202
• Device Sequence Number: 20831089
• Product Code: JDC
• UDI-Device Identifier: 00889024271463
• UDI-Public: (01)00889024271463(17)250927(10)64714237
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/13/2024

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: 09/27/2025
• Device Catalogue Number: 00840009500
• Device Lot Number: 64714237
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 82 KG