MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. CPLT F&A KIT 3CC 15G END; 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	08/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient underwent the subchondroplasty procedure on the head of the right talus on (b)(6) 2017.The surgical and operative notes were received, and there were no complications noted during the procedure.An increase in pain was noted at two weeks postoperatively, and the pain levels receded after 6 months.The health care professional assessed the event as mild in intensity and possibly related to the procedure and device.The event was communicated on (b)(4) 2019.The patient will continue to be monitored.The dhr for the lot in question was reviewed and there were no anomalies related to the complaint condition.The device was not returned for investigation, as it remains implanted.
Event or Problem Description
Clinical study subject: (b)(6) experienced increased pain post scp.
Event or Problem Description
Clinical study subject 02-003 experienced increased pain post scp.
Additional Manufacturer Narrative
Per zimmer knee creations capa ca-05425, this medwatch was identified for remediation, as the products listed in d11 in the initial submission were components of the finished kit for which this medwatch was filed under and should not have been reported.

• Brand Name: CPLT F&A KIT 3CC 15G END
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8842416
• Report Number: 3008812173-2019-00038
• Device Sequence Number: 1412847
• Product Code: OJH
• UDI-Device Identifier: 00889024205352
• UDI-Public: 00889024205352
• 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,Followup
• Report Date (Section B): 09/11/2020

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: 03/24/2020
• Device Model Number: N/A
• Device Catalogue Number: 514.315
• Device Lot Number: KC04058
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2019
• Device Age: 28 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/14/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN 201.030, LN 10979; PN 308.151, LN 34981; PN 308.151, LN 36493; PN 201.030, LN 10979; PN 308.151, LN 34981; PN 308.151, LN 36493
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR
• Patient Weight: 64