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

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544)
Date of Event	04/01/2021
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.
Event or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: SUBCHONDROPLASTY FOOT & ANKLE KIT 3CC SIDE 11GA X 120MM
• Common Device Name: 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
• Report Number: 3008812173-2021-00004
• Device Sequence Number: 1480081
• Product Code: OJH
• UDI-Device Identifier: 00889024205338
• UDI-Public: (01)00889024205338(17)230611(10)KC06917
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White