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	Extravasation (1842)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient experienced an adverse event of intraarticular leakage in the medial tibial plateau during the initial subchondroplasty (scp) procedure.Treatment involved port injection scope lavaged and debrided with no residual accufill in the joint space.It was reported this event was possibly related to the subchondroplasty study procedure and possibly related to the accufill implant.This complaint is being treated as a serious injury and will be investigated further.The device cannot be returned for investigation since it remains implanted.As additional information about the event is reported, a supplemental report will be submitted with any additional findings.
Event or Problem Description
Clinical study subject (b)(6) experienced intra-articular leakage of accufill in the medial tibial plateau.
Additional Manufacturer Narrative
A patient experienced an adverse event of intraarticular leakage in the medial tibial plateau during the initial subchondroplasty (scp) procedure on (b)(6) 2019.A medial partial meniscectomy and debridement were performed concomitantly.The case proceeded as normal but extravasation was observed post accufill injection.The surgeon observed the presence of accufill in the joint space as was able to remove it with lavage and debridement under scope visualization.All extravasated accufill was removed from the joint space.Surgical notes indicate that the case was completed as anticipated with less than 10 minutes impact on overall surgery, and the patient was transported to the recovery room stable.The patient is retained in the study and will continue to be monitored.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.
Event or Problem Description
Clinical study subject (b)(6) experienced intra-articular leakage of accufill in the medial tibial plateau.

• Brand Name: SUBCHONDROPLASTY
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8599351
• Report Number: 3008812173-2019-00029
• Device Sequence Number: 11333002
• Product Code: OJH
• UDI-Device Identifier: 00889024205314
• UDI-Public: 00889024205314
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• 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: 09/09/2021
• 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: 7 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 08/07/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN 307.032 LN 39230; PN 307.034 LN 38233
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 102