MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY; SCP KIT

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

Clinical study subject (b)(6) returned to the clinic for an unscheduled visit on (b)(6) 2018 for increased pain.It was noted that the subject has a possible stress fracture of the medial femoral condyle around their injection site, which was noted on x-ray on (b)(6) 2019.The event is ongoing.The device cannot be returned for investigation since it was implanted.As additional information about the event is reported, a supplemental report will be submitted with any additional findings.

Event Description

Clinical subject (b)(6) experienced paint and possible stress fracture after scp.

Manufacturer Narrative

Additional information from the clinical project lead was provided about the event on (b)(6) 2019.The patient had returned to the physician's office with a ct scan confirming a stress fracture; the patient has been diagnosed with a displaced mfc fracture and has been referred for a knee arthroscopy consultation.The final visit notes were also received.The complaint has been re-routed and investigated further.Once the investigation is complete, a supplemental report will be submitted.

Event Description

Clinical subject (b)(6) experienced pain and possible stress fracture after scp.

Manufacturer Narrative

Clinical study subject (b)(4) is being retained in the rct study and will be monitored for ongoing changes in condition.If further information becomes available about the event, a supplemental report will be submitted.The dhr for the finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.

Event Description

Clinical subject (b)(4) experienced pain and possible stress fracture after scp.

Event Description

Clinical subject (b)(6) experienced pain and possible stress fracture after scp.

Manufacturer Narrative

After the initial scp procedure, patient returned to the clinic for an unscheduled visit on (b)(6) 2018 for increased pain.It was noted that the subject has a possible stress fracture of the medial femoral condyle around their injection site, which was noted on x-ray on(b)(6) 2019.Additional information from the clinical project lead was provided about the event on (b)(6) 2019.The patient had returned to the physician's office with a ct scan confirming a stress fracture; the patient has been diagnosed with a displaced mfc fracture and has been referred for a knee arthroscopy consultation.The final visit notes were received.The surgeon has noted the apparent presence of a stress fracture and recommended the patient for tka over conservative, non-operative treatment.In the hcp's opinion, the patient¿s body would not be able to heal the fracture.The patient went under the care of another surgeon so it is unclear if the patient progressed on to tka or selected conservative care.This complaint is being closed on the assessment of progression of disease.It is unclear from the surgeons notes if the stress fracture was related to the scp or due to compromised patient health as indicated by recommending tka over conservative care.The dhr for the finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.The device was not returned for the investigation, as it remained implanted in the patient.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8331374
• MDR Text Key: 135879990
• Report Number: 3008812173-2019-00006
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2019,07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2020
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC04323
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2019
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 75