MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY ACCUFILL KNEE KIT 5CC 11G; BONE MATERIAL SUBSTITUTE

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 08/05/2020

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 was used.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.

Event Description

It was reported that the patient experienced severe, atraumatic lateral pain one (1) year following subchondroplasty with use of accufill injection.Attempts have been made and no additional information is available at this time.

Event Description

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: SUBCHONDROPLASTY ACCUFILL KNEE KIT 5CC 11G
• Type of Device: BONE MATERIAL SUBSTITUTE
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 10506782
• MDR Text Key: 206094189
• Report Number: 3008812173-2020-00015
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2022
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC05853
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 86