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	Pain (1994)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2019, a patient underwent a right knee scope with a subchondroplasty.There were no complications reported during the procedure; the patient had no other known pre-existing conditions that may have contributed to the event.The patient experienced increased pain following the subchondroplasty procedure and is in ambulating with crutches.He had follow-up mri which showed increased edema insitu, those images will be reviewed as a part of the investigation.The product was not returned for the investigation, as it remains implanted in the patient.Once additional information becomes available, a follow up report will be submitted.Implant remains in patient.
Event or Problem Description
Patient has increased pain since (b)(6) 2019 scp and scope.
Event or Problem Description
Patient has increased pain and increased edema since (b)(6) 2019 scp and scope.
Additional Manufacturer Narrative
Per zimmer knee creations capa ca-05425, this medwatch was identified for reassessment and was determined to not be a reportable event after the review of medical records by the hcp team in warsaw.It was determined that the accufill was well placed and not too much volume.Additional follow-up notes stated that the fracture had progressed to osteonecrosis with early collapse of the articular surface, which occurs in approximately 50% of macroscopic subchondral fractures.The surgeon / patient subject matter expert believes the patient had avn (avascular necrosis) that collapsed.Review of the ifu notes accufill is contraindicated for use in areas of nonviable bone or areas not capable of supporting and anchoring the implant.Avascular necrosis is not a risk of accufill, but a contraindication.As noted, the most likely scenario is that by the time the scp / accufill procedure was performed, it was already too late to stop the natural history of the disease.
Event or Problem Description
Patient has increased pain and increased edema since (b)(6) 2019 scp and scope.
Additional Manufacturer Narrative
The patient underwent the initial subchondroplasty procedure on their right knee in the distal femur on (b)(6) 2019.In the weeks following surgery the patient has had increasing pain in the knee.Pre-op and post-op mri were provided and reviewed by a clinical radiologist familiar with the scp procedure and made the following observations: the initial mri showed meniscal tear with altered mechanics and a clear, macroscopic subchondral stress fracture.The bone substitute material looked like it was well placed, and not too much volume.The post-op mri looks like it has progressed to osteonecrosis, with early collapse of the articular surface (as 50% of macroscopic subchondral fractures do).Although a definitive root cause could not be determined for the complaint condition, one possibility could be by the time the scp surgery treatment was done it was too late to arrest the natural history of the disease.In summary, it is possible the patient had early signs of bone degradation and necrosis in the distal femur possibly due to other systemic issues.At the time of surgery the necrosis had possibly advanced to where treatment would not be effective.The scp surgery may or may not have contributed to the advancing bone necrosis but in the short amount of time to post-op mri, it is unlikely the treatment was the cause of the advanced necrosis in that short amount of time elapsed.The exact cause or factors/details of the complaint event are unable to be determined given the information available.The investigation findings were shared with the responsible surgeon, as requested.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: 9570678
• Report Number: 3008812173-2020-00001
• Device Sequence Number: 10858116
• Product Code: OJH
• UDI-Device Identifier: 00889024205260
• UDI-Public: 00889024205260
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 11/06/2020

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: 08/29/2021
• Device Model Number: N/A
• Device Catalogue Number: 402.202
• Device Lot Number: KC06211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/10/2019
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019; 12/10/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 08/25/2020; 11/06/2020
• 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 201.050, LN 102193; PN 303.250, LN H1495564; PN 307.032, LN 40004; PN 311.100, LN KC05878; PN 201.050, LN 102193; PN 303.250, LN H1495564; PN 307.032, LN 40004; PN 311.100, LN KC05878
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR