MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. KNEE CREATIONS SUBCHONDROPLASTY KNEE KIT 5CC, END-DELIVERY, 11GA. X 120MM; BONE SUBSTITUTE MATERIAL

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	07/16/2020
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 was used.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.
Event or Problem Description
It was reported that a patient experienced pain, swelling and sensitivity with medial tenderness following a subchondroplasty procedure utilizing an accufill injection.The patient was instructed to continue neurontin and pain medication for pain management.No intraoperative complications were identified and no extravasation was identified at the conclusion of the initial surgery.Attempts have been made for additional information, however, no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: KNEE CREATIONS SUBCHONDROPLASTY KNEE KIT 5CC, END-DELIVERY, 11GA. X 120MM
• Common Device Name: BONE SUBSTITUTE MATERIAL
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 10566444
• Report Number: 3008812173-2020-00016
• Device Sequence Number: 3552607
• Product Code: OJH
• UDI-Device Identifier: 00889024205321
• UDI-Public: (01)00889024205321
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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 Expiration Date: 11/11/2022
• Device Model Number: N/A
• Device Catalogue Number: 414.503
• Device Lot Number: KC06401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 01/29/2021
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 109