MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	00223200418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Unspecified Infection (1930)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery approximately two and a half (2.5) months post-implantation due to experiencing a perioprosthetic bone fracture after falling, as well as an underlying infection.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01680.D10: item# 00223200418; lot# 65573115.Item# 00787101361; lot# 65473528.Item# 802203202; lot# 2999580.Item# 00800595232; lot# 63608860.G2: foreign - event occurred in australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 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.Images assessed but not sent to mmi as the background of the or obscures the view of the implants in the x-rays.Sending the images would not enhance the investigation.Review of the device history record(s) identified no deviations or anomalies during manufacturing.It was reported the cables were placed for prophylactic banding.As the cables performed their intended function, no device problem was identified regarding the cables.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.

• Brand Name: CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 17191409
• Report Number: 0001822565-2023-01681
• Device Sequence Number: 7338373
• Product Code: KTT
• UDI-Device Identifier: 00889024039513
• UDI-Public: (01)00889024039513(17)320905(10)65576873
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151907
• 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): 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 00223200418
• Device Lot Number: 65576873
• 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: 06/04/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 73 KG