MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE-READY CABLE GRIP SYSTEM CABLE FOR BONE PLATE 1.8MM; TRAUMA IMPLANT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: canada d10 - medical product: catalog #: 00223200318, cable for bone plate 1.8 mm diameter 24 in, lot # 62710265 catalog #: 00223200318, cable for bone plate 1.8 mm diameter 24 in, lot # 63015141 catalog #: 00223200318, cable for bone plate 1.8 mm diameter 24 in, lot # 63015141 h3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient had an initial left total hip arthroplasty placed approximately 16 years ago.It was further reported that the patient underwent a second revision about 2 years ago due to instability and chronic periprosthetic fracture.During the revision, the surgeon noted that the cerclage wires had all essentially failed with several from the initial fixation found broken.The plate and all cables were removed, and a trochanteric bolt was placed along with new cerclage wires for fixation.The head and liner were also exchanged without complication.The patient continued to experience nonunion following the revision.Attempts have been made and there is no further information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).The reported event is confirmed as medical records were provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: wires used in the past had all essentially failed.Several broken wires from original fixation removed ¿ manufacturer unknown.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.

• Brand Name: CABLE-READY CABLE GRIP SYSTEM CABLE FOR BONE PLATE 1.8MM
• Common Device Name: TRAUMA IMPLANT
• 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: 19679981
• Report Number: 0001822565-2024-02247
• Device Sequence Number: 17855325
• Product Code: HRS
• UDI-Device Identifier: 00889024039490
• UDI-Public: (01)00889024039490(17)290930(10)64550613
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 11/26/2024

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 Model Number: N/A
• Device Catalogue Number: 00223200318
• Device Lot Number: 64550613
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2019
• 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 Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White