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	03/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient underwent an initial subchondroplasty (scp) procedure on (b)(6) 2019.The patient returned to the clinic for an unscheduled visit on (b)(6) 2019 for increased pain, likely related to soft tissue/it band.The patient was given a corticosteroid injection in the knee and prescribed physical therapy.The clinical project lead was notified on april 12th, 2019 and provided the operative notes.The event is ongoing.This complaint is being treated as a serious injury and will be investigated further.Once additional information becomes available, a follow-up report will be submitted.
Event or Problem Description
Clinical subject (b)(6) experienced increased pain after scp surgery.
Additional Manufacturer Narrative
On (b)(6) 2019 the patient received scp treatment on lateral femoral condyle and lateral tibial plateau.A lateral partial meniscectomy and debridement were performed concomitantly.Surgical notes indicate the case proceeded as anticipated, and there were no intraoperative adverse events noted.Patient returned for routine 3 month visit and reported increased knee pain initiating (b)(6) 2019.Radiographs of the right knee over the area of the subchondroplasty lateral femoral condyle and lateral tibial plateau all look to be normal and no evidence of stress fracture or any irregularities, and the patient still has good maintenance of the joint space.Office diagnosis was that pain was potentially soft tissue/ it band and treated with cortisone injection.Though the surgeon indicated that event is possibly related to scp procedure, the it band is not inside of the treatment area.This complaint is being closed as a clinical observation but unrelated to the scp procedure.The patient is retained in the study and so will continue to be monitored for additional adverse events.If further information is obtained, the complaint will be reopened and further investigated.The dhr for the lot in question was reviewed, and no anomalies related to the complaint condition were noted.The product was not returned for evaluation, as it remains implanted in the patient.
Event or Problem Description
Clinical subject (b)(6) experienced increased pain after scp surgery.

• Brand Name: SUBCHONDROPLASTY
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8599334
• Report Number: 3008812173-2019-00028
• Device Sequence Number: 19335567
• Product Code: OJH
• UDI-Device Identifier: 00889024205314
• UDI-Public: 00889024205314
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/01/2019

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: 08/07/2020
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC04323
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 17 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 08/05/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Weight: 69