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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Seizures (2063); Weakness (2145); Reaction (2414)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 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 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
• Common Device Name: BONE SUBSTITUTE MATERIAL
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 10566454
• Report Number: 3008812173-2020-00017
• Device Sequence Number: 19720875
• Product Code: OJH
• UDI-Device Identifier: 00889024205352
• UDI-Public: (01)00889024205352
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 24 YR