MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP SRS NEXEL 70MM DST BDY LT; PROSTHESIS, ELBOW

Model Number	110029826
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Dob - unknown month and day in (b)(6).Report source: foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.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: 0001825034 - 2021 - 02029.
Event or Problem Description
It was reported that the patient underwent an initial left segmental elbow procedure.Subsequently, the patient was revised due to spontaneous disassociation of the intercalary segment from the distal body.The intercalary segment was replaced, and the event was resolved.
Additional Manufacturer Narrative
Reported event was confirmed by review of medical records.Review of the available records identified that there was spontaneous implant disassociation of the distal body and intercalary segments.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMP SRS NEXEL 70MM DST BDY LT
• Common Device Name: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12149456
• Report Number: 0001825034-2021-02030
• Device Sequence Number: 4723848
• Product Code: JDC
• UDI-Device Identifier: 00880304806023
• UDI-Public: (01)00880304806023
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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 Model Number: 110029826
• Device Catalogue Number: 110029826
• Device Lot Number: 504710R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4).; (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 77