MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. KNEE CREATIONS SUBCHONDROPLASTY FOOT & ANKLE KIT 3CC, END-DELIVERY, 15GA X 60; BONE SUBSTITUTE MATERIAL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Seizures (2063); Weakness (2145); Reaction (2414)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient felt weak and nauseous immediately following a subchondroplasty procedure.The patient continued to deteriorate and was transferred to another hospital for treatment of a potential allergic reaction/seizures.The patient was discharged the following day with no additional adverse consequences reported.Attempts have been made and no additional information is available at this time.

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 product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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: KNEE CREATIONS SUBCHONDROPLASTY FOOT & ANKLE KIT 3CC, END-DELIVERY, 15GA X 60
• Type of Device: BONE SUBSTITUTE MATERIAL
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 10566454
• MDR Text Key: 207911814
• Report Number: 3008812173-2020-00017
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00889024205352
• UDI-Public: (01)00889024205352
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2022
• Device Model Number: N/A
• Device Catalogue Number: 514.315
• Device Lot Number: KC06260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 24 YR