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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Subject (b)(6) experiencing left knee pain after scp surgery.
Event or Problem Description
Subject 06-010 experiencing left knee pain after scp surgery.
Additional 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 or Problem Description
Subject (b)(6) experiencing left knee pain after scp surgery.
Additional 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
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9886139
• Report Number: 3008812173-2020-00008
• Device Sequence Number: 2728356
• Product Code: OJH
• UDI-Device Identifier: 00889024205314
• UDI-Public: 00889024205314
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 03/11/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 07/28/2020; 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN 308.032.2 LN 39583; PN 314.050.0 LN 102182
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 94