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 Pain (1994)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

Patient (b)(6) underwent an initial subchondroplasty procedure on (b)(6) 2019.On (b)(6) 2020, the patient returned to their health care provider with left knee pain and underwent a cortisone injection.Zimmer knee creations was notified on (b)(6) 2020.The health care professional determined that the event was possibly related to the subject¿s study procedure but not related to accufill.The patient had a right tka, has also previously undergone pt, bracing, activity modification, corticosteroid injections and nsaids for left knee pain.The patient has been previously diagnosed with left knee pain and left patellofemoral osteoarthritis with an onset date of (b)(6) 2019.The patient had been previously diagnosed with osteoarthritis of the left knee with an onset date of (b)(6) 2019.Operative notes were provided for aid in the investigation.The device was not returned for the investigation, as it remains implanted in the patient.Once additional information about the event becomes available, a supplemental report will be submitted.

Event Description

Subject (b)(6) experiencing left knee pain after scp surgery.

Event Description

Subject 06-010 experiencing left knee pain after scp surgery.

Manufacturer Narrative

Per zimmer knee creations capa ca-05425, this medwatch was identified for remediation, as the products listed in d11 in the initial submission were components of the finished kit for which this medwatch was filed under and should not have been reported.

Event Description

Subject (b)(6) experiencing left knee pain after scp surgery.

Manufacturer Narrative

Clinical study (b)(6) underwent an initial subchondroplasty treatment surgery of the left knee (b)(6) 2019.The clinical notes were provided for the investigation.On (b)(6) 2020 the patient returned to the doctor¿s office due to ongoing pain and was treated with a cortisone injection.The treating surgeon, stated the adverse event could possibly be related to the arthroscopic surgery or scp procedure but not related to the accufill implant.The patient had previously undergone a right tka, physical therapy, bracing, activity modification, corticosteroid injections, and nsaids for left knee pain.There is no other information available outside of the clinical ae report which states that the procedure is not directly related to the complaint incident but could possibly be related.There is no further evidence or information to determine cause of the event so the finding for this complaint is indeterminate.The nature of the reporting clinician on the ae report is not to rule out any possibilities but otherwise there is no supporting evidence or information to determine cause.The product was not returned for the investigation, as it remains implanted in the patient.The dhr for the finished goods lots were reviewed, and no anomalies related to the complaint condition were noted.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9886139
• MDR Text Key: 191538886
• Report Number: 3008812173-2020-00008
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00889024205314
• UDI-Public: 00889024205314
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2021
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC05447
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 14 MO
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PN 308.032.2 LN 39583; PN 314.050.0 LN 102182
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 94