MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. CPLT F&A KIT 3CC 11G 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	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject 09-005 underwent an initial subchondroplasty surgery on (b)(6) 2019.For this subject, two lesions were treated in the left distal fibula: one was treated anteromedial with 1 cc accufill mixed with saline, and the other was treated posterolateral with 2 cc accufill mixed with saline.Concomitant procedures were a deltoid ligament repair, impingement, osteophyte removal, synovectomy, syndesmosis reconstruction, fibular osteotomy/fixation, and proximal and distal bone grafts.There were no intraoperative complications reported.The patient experienced an increase in pain approximately three months post-operatively on (b)(6) 2019, but had also undergone an additional procedure on the index ankle in (b)(6) 2019.Zimmer knee creations was notified of the event on (b)(6) 2020.The event was evaluated by the health care professional as possibly related to the device and possibly related to the procedure, but stated that the increase is likely due to recovery from the more recent procedure.The subject has not received treatment for the pain increase at this time and the event is ongoing.Once additional information becomes available, an additional report will be submitted.The product was not returned for the investigation, as it remains implanted in the patient.
Event or Problem Description
Subject 09-005 adverse event increase in pain.
Event or Problem Description
Clinical subject (b)(6) adverse event increase in pain.
Additional Manufacturer Narrative
Clinical subject (b)(6) underwent the initial subcondroplasty procedure on (b)(6) 2019, and the surgical documentation for the event were provided.For this subject, two lesions were treated in the left distal fibula, one was treated anteromedial with 1 cc of accufill mixed with saline, and one was treated posterolateral with 2 cc accufill mixed with saline.Concomitant procedures were a deltoid ligament repair, impingement, osteophyte removal, synovectomy, synodemosis reconstruction, fibular osteotomy/fixation, and proximal and distal bone grafts.The patient experienced an increase in pain approximately 3-month post-op in (b)(6) 2019, but had also undergone an additional procedure on the index ankle in (b)(6) 2019.The event was evaluated by the investigator as possibly related to the device and procedure, but said the increase is likely due to recovery from the more recent procedure.The investigator has not yet evaluated intensity.Subject has not received treatment for the pain increase at this time and the event is ongoing.Numeric pain scores: 6/10, 1/10, 4/10, 8/10, 3/10 at baseline, 2 weeks, 6 weeks, 3 months, 6 months respectively.There is no other information available outside of the clinical adverse event report which states that the procedure is not directly related to the complaint incident but could possibly be related.There is no further evidence or information to determine cause of the event so the finding for this complaint is indeterminate.The nature of the reporting clinician on the adverse event report is not to rule out any possibilities but otherwise there is no supporting evidence or information to determine cause.The device was not returned for the investigation, as it remains implanted in the patient.The dhr for the finished goods were reviewed, and no anomalies related to the complaint condition were noted.
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.
Event or Problem Description
Clinical subject (b)(6) adverse event increase in pain.

• Brand Name: CPLT F&A KIT 3CC 11G END
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9886119
• Report Number: 3008812173-2020-00007
• Device Sequence Number: 16826381
• Product Code: OJH
• UDI-Device Identifier: 00889024205345
• UDI-Public: 00889024205345
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 02/21/2022
• Device Model Number: N/A
• Device Catalogue Number: 514.303
• Device Lot Number: KC05829
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 02/28/2020; 02/28/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 07/28/2020; 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 308.034.2 LN 40438; PN 308.034.2 LN 41311; PN 314.030.0 LN SA185024
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR