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

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2018, a patient underwent an initial subchondroplasty procedure, where 0.4 cc and 0.5 cc of accufill was mixed with saline was injected into the talar dome and navicular, respectively.Synovectomy, hallux nail chemical matrixectomy, and achilles and ankle amino injection were performed concomitantly.On (b)(6) 2019, the patient returned and complained of pain levels similar to those of pre-surgery, an mri revealed medial and talar dome lesions on index side.The patient then underwent a left ankle arthroscopy with hemorrhagic synovitis concerning for pvns and al osteochondral lesion debridement with cartilage scaffold placement, am osteochondral lesion microfracture.No intraoperative complications were reported.The device will not be returned for investigation, as it remains implanted in the patient.The investigation is on-going, once additional information about the event becomes available, a supplemental report will be submitted.Device remains implanted in the patient.
Event or Problem Description
Study participant 02-009 revised surgery at scp site due to pain.
Additional Manufacturer Narrative
Patient (b)(6) in scp outcomes in the foot/ankle underwent the index procedure on (b)(6) 2018.The patient underwent the scp procedure and received 0.4cc accufill in the talar dome and 0.5cc accufill in the navicular, both of the left ankle.A synovectomy, and hallux nail chemical matrixectomy and achilles and ankle amino injection were concomitantly performed during the index procedure, also on the left ankle.There were no intraoperative complications reported.The patient experienced pain relief at six weeks post-op, but reported high pain levels at three months post-op.Revision surgery was performed on (b)(6) 2019 (1.5 years after index procedure), where it was determined that the patient had developed tarsal tunnel syndrome, an osteochondral lesion defect, and a venous malformation of the left ankle.The event was evaluated by the investigator and determined to be possibly related to the procedure but not related to the scp device.The revision event can be most likely attributed to the patients¿ tarsal tunnel syndrome.The revision surgery included left ankle scope with extensive debridement, tarsal tunnel release, osteochondral lesion repair with cartilage graft, medial calcaneal branch release, and excision of the venous malformation/cyst on the flexor retinaculum.It was reported that the patient has recovered.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
Study participant (b)(6) revised surgery at scp site due to pain.

• Brand Name: SUBCHONDROPLASTY
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9356246
• Report Number: 3008812173-2019-00052
• Device Sequence Number: 2133655
• Product Code: OJH
• UDI-Device Identifier: 00889024205345
• UDI-Public: 00889024205345
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 04/09/2020

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: 06/16/2020
• Device Model Number: N/A
• Device Catalogue Number: 514.303
• Device Lot Number: KC04275
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/25/2019
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 04/09/2020
• 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: 49 YR