MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH LEFT FOR CEMENTED USE ONLY; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED/EXTREMITIES

Catalog Number	00840001407
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: unknown, unknown bone cement; lot#: unknown.G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested from the hospital but not returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial elbow surgery approximately three (3) weeks ago.Subsequently, the patient was revised the next day due to malpositioning of the implants.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.H6: component codes: mechanical (g04) - stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two views left elbow demonstrate a left elbow arthroplasty with intact humeral component.Proximal ulnar resection with bony fragmentation and heterotopic ossification of the proximal ulnar and radius.Radiolucency is seen along the distal humeral and along the entire ulnar component.Radiolucency along the distal humeral component.Soft tissue swelling overlies the olecranon with subcutaneous emphysema.Vascular calcifications.Differential diagnosis includes posttraumatic change, postsurgical change or prior trauma.Correlate clinically.There is a gap between the proximal ulnar and the joint space, of uncertain etiology and presumably expected.Overall size of hardware appears to be appropriate.The root cause of the reported issue is attributed to user error.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 FOR CEMENTED USE ONLY
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED/EXTREMITIES
• 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: 17661965
• Report Number: 0001822565-2023-02357
• Device Sequence Number: 20604986
• Product Code: JDC
• UDI-Device Identifier: 00889024271227
• UDI-Public: (01)00889024271227(17)330326(10)65666479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/01/2024

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 Catalogue Number: 00840001407
• Device Lot Number: 65666479
• 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: 08/06/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown