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

Model Number N/A

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

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source : (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as it 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 experienced pain and distortion three (3) months following a knee subchondroplasty procedure.The patient received multiple injections and eventually required an additional joint distraction procedure.The distraction frame was removed routinely one month later and no further pain was reported.Attempts are being made to obtain additional information, however, no additional information is available at this time.

Manufacturer Narrative

Upon receipt of additional medical records, it was determined that the post-operative complication is related to disease progression and not zimmer biomet devices.

Event Description

Upon receipt of additional medical records, it was determined that the post-operative complication is related to disease progression and not zimmer biomet devices.

• Brand Name: KNEE CREATIONS ACCUFILL SUBCHONDROPLASTY BONE SUBSTITUTE MATERIAL 5CC
• Type of Device: BONE SUBSTITUTE MATERIAL
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 10560003
• MDR Text Key: 207718143
• Report Number: 3008812173-2020-00018
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• PMA/PMN Number: K190814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

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 Model Number: N/A
• Device Catalogue Number: 201.150
• Device Lot Number: 101978-0399
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 10/06/2020
• 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