MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. ACCUPORT; CANNULA

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	08/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient underwent an initial subchondroplasty procedure on (b)(6) 2017, and no other concomitant procedures were performed.A review of the operative notes from the index procedure indicates the procedure proceeded as anticipated.The patient returned to the due to post-operative pain, and was prescribed physical therapy.Patient pain levels returned to normal after 24 months.The health care professional assessed the adverse event and determined that it was possibly related to the procedure and implant.This patient will continue to be monitored by the treating surgeon.The device in question was not returned, as it remains implanted.A review of the dhr was conducted on the lot in question, and no anomalies related to the complaint condition were noted.
Event or Problem Description
Clinical subject (b)(6) experienced increased pain post scp.

• Brand Name: ACCUPORT
• Common Device Name: CANNULA
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8842112
• Report Number: 3008812173-2019-00037
• Device Sequence Number: 19182586
• Product Code: FGY
• UDI-Device Identifier: 00889024205239
• UDI-Public: 00889024205239
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2020
• Device Model Number: N/A
• Device Catalogue Number: 308.151
• Device Lot Number: 36904
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2019
• Device Age: 28 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/30/2019
• 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: 30 YR
• Patient Weight: 52