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	Necrosis (1971)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2019, it was reported that a patient who had underwent a subchondroplasty procedure on their knee on (b)(6) 2019 had possible signs of avascular necrosis.The sales representative who attended the case stated that there were no issues identified during the initial procedure, and there was no delay during the procedure.The product was not returned for the investigation, as it remains implanted in the patient.Once additional information about the event becomes available, a supplemental report will be submitted.
Event or Problem Description
Possible avn 3 months after surgery.
Event or Problem Description
Possible avn 3 months after surgery.
Additional Manufacturer Narrative
The patient underwent a subchondroplasty procedure of the knee on (b)(6) 2019, and there were no intraoperative complications noted.The quality of the bone surrounding the injection site(s) is unknown.The proper surgical technique was followed, only saline in the appropriate quantity was mixed with the bsm, and there were no issues or delays during the surgery.The sales rep approximated that between 2-4cc of accufill was injected into the knee, but it was not specified which specific sites received what amount.On (b)(6) 2019, three months following the procedure, the patient reported pain in the knee.Mri images showed what the surgeon described as possible avn, which was not confirmed.An mri disc was sent for review but not received by the complaint handling team; multiple attempts were made to find and obtain the disc without success.No additional information was provided, and no additional medical intervention was performed at the time.It was not reported whether the surgeon believes that the avn was related to either the procedure or the product.In the product history, there have been reports of the injected material being misconstrued as avn due to its appearance in mri (no water signal).There have also been experience of patients with a history of avn being treated with subchondroplasty where the avn has progressed and led to knee pain.It is also possible that an over-injection or high-pressure injection of material could also led to the development of avn.In this case there is no information available to confirm any avn or to determine the possible hazards involved; therefore the cause of this incident is unable to be determined.The dhr for the raw material and finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.The product was not returned for the investigation, as it remains implanted in the patient.

• Brand Name: SUBCHONDROPLASTY
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9323696
• Report Number: 3008812173-2019-00051
• Device Sequence Number: 13915632
• Product Code: OJH
• UDI-Device Identifier: 00889024205314
• UDI-Public: 00889024205314
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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): 05/12/2020

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: 03/02/2022
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC05852
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2019
• Device Age: 9 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 05/13/2020
• 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: 70 YR