MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY; SCP KIT

Model Number N/A

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

Patient Problem Necrosis (1971)

Event Date 03/02/2018

Event Type  Injury  

Manufacturer Narrative

Patient presents with possible avascular necrosis (avn) after a scp procedure.Operative notes from the procedure were received, and the index procedure proceeded without incident on (b)(6) 2018.Patient returned to the doctor on (b)(6) 2019 with pain and swelling in the right knee.A mri scan of his right knee shows marked edema in the marrow of the medial femoral condyle and stable degenerative changes of the medial compartment and possible avn.Imaging was received from the company representative and will be used as an aid in the investigation.The investigation is ongoing and once more information becomes available, a supplemental report will be submitted.The product will not be returned for investigation, as it remains implanted.

Event Description

Failed scp procedure possibly led to avn.

Event Description

Failed scp procedure possibly led to avn.

Manufacturer Narrative

Mri images were provided for aid in the investigation; the images were sent to hcps for review.The patient had advanced degeneration after scp surgery which may be natural progression of the pre-operative disease or may be linked to over-injection of the condyle.4cc of accufill was reported injection for this small location in the knee ¿ typically 2cc is injected.Clinical reviewers pointed out that patient was of advanced age with possible slower healing and advanced degeneration of the bone ¿ scp may possibly not be appropriate for this patient.The complaint condition could be linked to over-injection, patient natural disease progression, or possible trauma or other systemic issues.The specific cause to this complaint cannot be determined from the information available.A review of the dhr was conducted on the lot in question and there were no anomalies related to the complaint condition.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8390428
• MDR Text Key: 137824474
• Report Number: 3008812173-2019-00009
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2020
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC04620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 14 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/08/2019
• 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: 76 YR
• Patient Weight: 100