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

Catalog Number	00223200318
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 00223200318, cable for bone plate 1.8 mm diameter 24 in.(610 mm) length; lot#: 61426610.Item#: 00223200318, cable for bone plate 1.8 mm diameter 24 in.(610 mm) length; lot#: 62867158.Item#: 00223200303, bone plate 305 mm length 10 holes; lot#: 63053378.Item#: 00223200302, bone plate 246 mm length 8 holes; lot#: 62817369.G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, the product was requested from the hospital and 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 a patient underwent an initial total hip arthroplasty approximately eleven (11) years ago and an open reduction internal fixation due to periprosthetic fracture approximately two (2) years and six (6) months after the patient's initial surgery.Subsequently, the patient was experiencing pain, numbness, and left sided sciatica and underwent a revision surgery approximately one (1) month ago.During the revision it was discovered that the femoral stem had loosened.There was no presence of an infection.All of the femoral components and plates were revised.The acetabular components were left implanted in the patient.
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.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: eight views of the left femur demonstrate a left total hip arthroplasty with screw fixation of the acetabular cup.Plate and screw fixation devices with multiple cerclage wires are seen throughout the femoral diaphysis.No definite fracture seen.Osteopenia is present.Prominent heterotopic ossification is seen along the greater trochanter possibly bridging to the superior acetabulum.Vascular calcifications.No problem was found with these devices.Per nursing review "it was reported that the patient experienced pain with loosening and subsidence of the femoral stem.Radiology reports indicate the trauma plate and cables remained intact and stable without signs of loosening, migration, fracture, or other complications, and the bone under the trauma hardware had adequately healed.When revising a femoral stem, it is necessary to remove the pre-existing trauma hardware." 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 DIAMETER
• Common Device Name: PLATE, FIXATION, BONE/TRAUMA
• 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: 19136246
• Report Number: 0001822565-2024-01313
• Device Sequence Number: 14632875
• Product Code: HRS
• UDI-Device Identifier: 00889024039490
• UDI-Public: (01)00889024039490(17)241031(10)62867158
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• 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): 09/20/2024

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 00223200318
• Device Lot Number: 62867158
• 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: 03/27/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2014
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 82 KG