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 No Code Available (3191)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

Subject oberd id (b)(6) of the subchondroplasty observational knee study underwent a right knee arthroscopy and medial meniscectomy on (b)(6) 2020.This event was discovered by the project manager during a data review of the subject¿s four-year follow-up visit.The patient previously underwent scp procedure and partial medial meniscectomy on (b)(6) 2016.Due to covid-19, the clinical coordinators and investigators are not currently in clinic, and the coordinator has been unable to get the severity and relatedness of the event from the hcp.In an effort to be conservative, this complaint will be treated as a serious injury and will be investigated further.The product was not returned for the investigation, as it remains implanted in the patient.The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed.Once additional information about the event becomes available, a supplemental report will be submitted.

Event Description

Subject gas/oberd id (b)(6) right knee arthroscopy after scp.

Event Description

Subject gas/oberd id (b)(6) right knee arthroscopy.

Manufacturer Narrative

The event was initially received on april 1, 2020 and was submitted in an effort to be conservative, was treated as a serious injury would be investigated further.On june 10, 2020, the adverse event was assessed by the responsible health care professional, and the event was determined to be not related to the scp procedure or the device.The form was submitted as a part of the investigation by zimmer knee creations on june 30, 2020.On (b)(6) 2016, subject (b)(6) underwent an initial subchondroplasty procedure, and on (b)(6) 2020, the subject underwent an arthroscopy and medial meniscectomy.The scp and re-operation notes were reviewed as a part of the investigation.The scp preoperative and postoperative diagnosis was noted to be the same, per the operative notes provided by the clinical project lead: osteochondral defect, bone marrow edema and a complex tear of medial meniscus.On the right knee, an arthroscopy with meniscus repair and arthroscopy with chondroplasty/abrasion arthroplasty, and an orif proximal tibia fx (unicondylar) were performed.There were no complications noted during the surgery and it was noted that the quality of the procedure was satisfactory.On (b)(6) 2020, the patient returned to the operating room with a pre and post-operative diagnosis of complex tear or medial meniscus and other specified disorders of cartilage at unspecified sites.It was noted that the torn portion of the medial meniscus was contoured to stable tissue using motorized shaver and basket forceps.Additionally, the chondral lesions on the medial tibial plateau and medial femoral condyle were contoured to stable tissue using the 4.0 motorized shaver and radiofrequency device.There were no complications noted during the surgery, and it was noted that the patient tolerative the procedure well and was brought to the recovery room in stable condition.The dhr was unable to be reviewed, as the lot number for the device related to the event is unknown.The product was not returned for investigation, as the product remains implanted.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 10006286
• MDR Text Key: 191539121
• Report Number: 3008812173-2020-00010
• Device Sequence Number: 1
• Product Code: OJH
• 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
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2020
• Event Location: Hospital
• Date Manufacturer Received: 04/01/2020
• 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: 48 YR
• Patient Weight: 93