MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CERCLAGE CABLE WITH NEEDLE AND CRIMPS; FASTNER, FIXATION

Model Number 2232-11-13

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that the patient was revised due to pain and fracture of the implant.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g7, h1, h2, h3, h6, h10.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the patellar fixation wires are disrupted and displaced.Patellar fracture with subsequent fixation wire fracture as noted.On the first post-op image, fit and alignment are maintained.Subsequent image demonstrates wire failure as noted.Bone quality appears osteopenic.No signs of loosening, wear, radiolucency, or any or contributing factors are present.Fixation wire fracture is noted.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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: CERCLAGE CABLE WITH NEEDLE AND CRIMPS
• Type of Device: FASTNER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12281154
• MDR Text Key: 265176415
• Report Number: 0001822565-2021-02201
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 00889024039605
• UDI-Public: (01)00889024039605
• Combination Product (y/n): N
• PMA/PMN Number: K151848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2232-11-13
• Device Catalogue Number: 00223201113
• Device Lot Number: 64736554
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR