MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. CPLT KNEE KIT 5CC 11G SIDE; SCP KIT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2018, the patient underwent a right knee athroscopy, lysis of adhesions anterior notch adhesions manipulated under anesthesia, and a subchondroplasty.There were no intraoperative complications reported.On (b)(6) 2019, zimmer knee creations was notified that a patient had returned for treatment of decreased range of motion on (b)(6) 2019.The onset date was (b)(6) 2019, and the event was marked as resolved on (b)(6) 2019.It was noted that the subject did not gain any more motion over 20 degrees.The patient had previously reported that it was hard for them to stand due to their right knee.The product was not returned for the investigation, as it remains implanted in the patient.Once additional information becomes available about the event, a supplemental report will be submitted.
Event or Problem Description
Clinical study subject (b)(6) experienced decreased range of motion after scp.
Additional Manufacturer Narrative
The operative notes were received from the clinical procject lead and will be used as a part of the investigation.Once additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
Clinical study subject (b)(6) did not gain motion in knee.
Additional Manufacturer Narrative
Scp knee randomized controlled trial subject (b)(6) underwent the initial subchondroplasty procedure on (b)(6) 2018 for a single bone marrow lesion in their right medial tibial plateau.3cc of accufill were injected.A lavage, debridement, and synovectomy a were also performed concomitantly.No intraoperative adverse events were reported.At a follow-up on (b)(6) 2019, the subject underwent a right knee arthroscopic lysis of anterior notch adhesions under anesthesia, as the subject did not gain any more motion over 20 degrees and a flexion contracture was determined.There were 161 days between the index and follow-up procedures.Per the health care professional assigned to this case, this event was probably related to the study surgical procedure (scp with arthroscopy) and possibly related to the accufill implant.The operative notes of the reoperation were provided for the investigation.The surgeon noted significant synovitis and scarring globally in the suprapatellar pouch, medial and lateral gutters, and just anterior to the notch.It was also noted that signification bony overgrowth over the acl, causing mechanical impingement in extension.The surgeon used a full radius shaver to reduce the bony overgrowth.The anterolateral notch had overgrowth with soft tissue, causing mechanical impingement of the acl.Again, the surgeon used a full radius shaver to remove the excess tissue.The acl and pcl were inspected and determined to be stable without injury.The decision was made to cast the patient in extension.The postoperative condition was noted as stable with minimal blood loss.The event was most likely caused by the patient anatomy and clinical conditions.A review of the finished goods dhr was conducted, and there were no nonconformances related to the complaint condition noted.The device in question remains implanted in the patient and therefore was not returned for the investigation.
Event or Problem Description
Clinical study subject (b)(6) experienced decreased range of motion after scp.

• Brand Name: CPLT KNEE KIT 5CC 11G SIDE
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8995462
• Report Number: 3008812173-2019-00043
• Device Sequence Number: 3330425
• Product Code: OJH
• UDI-Device Identifier: 00889024205314
• UDI-Public: 00889024205314
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2020

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: 08/15/2021
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC05347
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/20/2019
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 08/13/2019; 08/13/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 11/14/2019; 01/29/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Weight: 89