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

Catalog Number	00840001407
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was part of a clinical study and underwent an initial implantation approximately five (5) years and seven (7) months ago.During a five (5) year follow-up visit, ulnar loosening was noted.The patient was also experiencing pain, osteolysis, and limited range of motion.The patient will not undergo revision surgery.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products item number: 00840004510 ; lot number: 77006009; item number: 00840009000 ; lot number: 63475165; item number: 00840009500 ; lot number: 63618393.G2: foreign - the event occurred in the uk.The customer has indicated that the product will not be returned to zimmer biomet for investigation and will remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00215.H6: proposed component code - mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Crf was provided and reviewed by a health care professional.Review of the available crf identified the following: (b)(6) 2021 limited range; (b)(6) 2023 moderate pain, proximal ulnar osteolysis, ulnar implant loosening.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report 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: ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH LEFT FOR CEMENTED USE ONLY
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• 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: 17954494
• Report Number: 0001822565-2023-02884
• Device Sequence Number: 20092077
• Product Code: JDC
• UDI-Device Identifier: 00889024271227
• UDI-Public: (01)00889024271227(17)270630(10)63656747
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: 63656747
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 92 KG