MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. CPLT KNEE KIT 5CC 11G SIDE; SCP KIT

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2019, subject 13-006 underwent an initial subchondroplasty procedure and a medial partial meniscectomy.Five cc's of accufill were implanted into the medial femoral chondyle and four cc's of accufill were implanted into the medial tibial plateau.Same part number and lot number were used for both lesions.During the procedure, extrusion of accufill into the knee joint during surgery was observed, most likely due to the accufill leaking through the medial femoral fissures, into the knee joint.The accufill fragments were removed with a shaver.The joint was thoroughly inspected to ensure no remaining fragments were present in the knee joint before closing.Zimmer knee creations was notified of the event on (b)(6) 2019.On the post-operative notes, it was noted that the patient was indicated as recovered.The device remains implanted and will not be returned for the investigation.Once additional information about the event becomes available, a supplemental report will be submitted.Remains implanted.
Event or Problem Description
13-006 had extrusion of accufill into the knee joint during surgery.
Additional Manufacturer Narrative
An email was received from the clinical project lead stating that the extravasation of accufill was again noted, now into the soft tissue surrounding the medial tibia plateau, during 6 week post-op x-rays.The investigation for this event is ongoing.Once additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
13-006 had extrusion of accufill into the knee joint during surgery.
Event or Problem Description
13-006 had extrusion of accufill into the knee joint during surgery.
Additional Manufacturer Narrative
Scp knee randomized controlled trial subject 13-006 was pre-operatively diagnosed with a medial meniscal tear and insufficiency fractures of the medial femoral condyle and the medial tibial plateau, all of the right knee.During the index procedure on (b)(6) 2019, the pre-op diagnosis was confirmed, and the surgeon performed an arthroscopic partial medial meniscectomy, a medial femoral condyle internal fixation with subchondroplasty, and a medial tibial plateau internal fixation with subchondroplasty, all of the right knee.During the meniscectomy, two-thirds of the medial meniscus was removed, and the remaining medial tissue had degenerative changes, unstable tears, and posterior root tears.4cc¿s of accufill were injected during the subchondroplasty procedure in the tibia, which was performed without incident and did not show any extravasation.5cc¿s of accufill were injected during the subchondroplasty procedure in the femur, which resulted in extravasation of the bone substitute material through open fissures in the femoral condyle from the patient¿s femoral insufficiency fractures.The extravasated material was removed with a shaver, and the joint was thoroughly inspected to ensure no remaining extravasated material was present in the joint before closing.The surgeon stated that the case may have ended twenty to thirty minutes sooner had the extravasation not occurred.Aside from the extravasation and delay, there were no further complications and the patient had overall minimal blood loss.It should be noted that the two lesions were addressed with scp kits from the same lot.The surgeon stated the surgical complication was only mild in intensity, and was definitely related to the surgical procedure and definitely related to the implant.It was specifically noted that the recommended surgical technique was followed for the product used.At the patient¿s 6-week follow-up on (b)(6) 2019, the physician noted that further extravasation of bone substitute material was seen in the soft-tissue surrounding the medial joint line on the patient¿s x-rays.X-rays were not provided for the investigation.A definitive root cause cannot be determined; however, this was likely due to the accufill leaking through the medial femoral fissures, into the knee joint.The patient has reported improved pain levels with weight bearing, has appropriate levels of motion and stability, and is progressing as expected during physical therapy.A review of the finished goods dhr was conducted, and there were no nonconformances related to the complaint condition noted.The device in question remains implanted in the patient and therefore was not returned for the investigation.

• Brand Name: CPLT KNEE KIT 5CC 11G SIDE
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9174429
• Report Number: 3008812173-2019-00048
• Device Sequence Number: 11465961
• Product Code: OJH
• UDI-Device Identifier: 00889024205314
• UDI-Public: 00889024205314
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 03/09/2020

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: 09/10/2021
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC05432
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2019
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/12/2019; 09/12/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 11/27/2019; 03/10/2020
• 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 LN102180.; PN 414.502 LN KC05432.; PN 201.050 LN102180
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 82