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

Model Number	2232-11-13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient was revised due to pain and fracture of the implant.
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.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
• Common Device Name: FASTNER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12281154
• Report Number: 0001822565-2021-02201
• Device Sequence Number: 2885809
• Product Code: JDQ
• UDI-Device Identifier: 00889024039605
• UDI-Public: (01)00889024039605
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 2232-11-13
• Device Catalogue Number: 00223201113
• Device Lot Number: 64736554
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR