MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY FOOT & ANKLE KIT 3CC SIDE 11GA X 120MM; FILLER, BONE

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544)

Event Date 04/01/2021

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.

Event Description

It was reported that the patient developed avascular necrosis approximately four (4) to five (5) months following a left ankle subchondroplasty injection.The patient is being treated with a brace and continues to experience pain, stiffness and difficulty with activities, tolerating with steroid therapy.Study notes did not note any abnormalities or complications during the injection of the subchondroplasty.No additional patient consequences were reported.

Manufacturer Narrative

Upon receipt of additional information, it was identified that the patient's avascular necrosis developed prior to the subchondroplasty procedure and did not worsen following the procedure.As the product did not cause or contribute to serious injury and there have been no allegations against the device, it has been determined that this event does not meet the definition of a complaint.

Event Description

No further event information available at the time of this report.

• Brand Name: SUBCHONDROPLASTY FOOT & ANKLE KIT 3CC SIDE 11GA X 120MM
• Type of Device: FILLER, BONE
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: leo munar ; 841 springdale drive; exton, PA 19341 ; 4848794553
• MDR Report Key: 12729668
• MDR Text Key: 279343306
• Report Number: 3008812173-2021-00004
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00889024205338
• UDI-Public: (01)00889024205338(17)230611(10)KC06917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: N/A
• Device Catalogue Number: 514.302
• Device Lot Number: KC06917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White