MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. ACCUFILL 5CC; BONE VOID FILLER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/21/2016

Event Type  Injury  

Manufacturer Narrative

Investigation is still on-going.This complaint is from a clinical study.A supplemental or follow up will be completed in a timely manner.Device not returned.

Event Description

Right knee medial compartment unicompartmental arthroplasty procedure (b)(6) 2016.

Manufacturer Narrative

The patient involved in this complaint is a female, (b)(6) at the time of the initial procedure.The patient's weight was (b)(6) with a bmi of 40.The patient had been seen by dr.(b)(6) for right knee pain and had failed multiple conservative treatments including corticosteroid injections, nsaids and activity modifications with continued severe and debilitating pain.An mri showed degenerative changes in the medial compartment with subchondral insufficiency fractures of both the medial femoral condyle and medial tibial plateau.A complex posterior horn meniscal tear was also noted.The patient consented to be part of the observational cohort study and reported a preoperative pain level of 8/10.The patient elected to undergo right knee arthroscopy and subchondropalsty on (b)(6) 2014 with dr.(b)(6).Dr.(b)(6) first placed accuport cannulas under fluoroscopic guidance into the medial femoral condyle and the proximal tibial plateau in the regions of insufficiency fracture identified on mri.Then 5 cc of accufill was injected into the medial femoral condyle and 5 cc was injected into the medial tibial plateau.The accufill was then allowed to cure while the arthroscopy was performed.Stretching and partial tearing to the acl was noticed under arthroscopic visualization; the pcl was normal.The entire medial femoral condyle had grade iiib to iiic changes.The medial meniscus was torn at the posterior horn and approximately 50% of the posterior horn was resected back to a smooth, stable base.Chondroplasty was performed on the medial femoral condye.The medial tibial plateau showed grade i-ii changes.The lateral compartment showed grade 0 changes with intact lateral meniscus.Grade ii-iii changes were noted on the trochlea with grade 0-i changes on the patella.No loose bodies were noted.All instrumentation was then removed.No complications were reported.The patient was placed on full strength aspirin twice daily for dvt prophylaxis and discharged to home the same day.The patient reported an improvement in pain to 1/10 at 6 weeks, and 0/10 at 3 months.However, at 6 months, the patient reported return of some pain to a level of 4/10.The patient also reported an improvement in ikdc scores from 28 preop to 50 at 6 weeks, 65 at 3 months and 79 at 6 months.However, during a follow-up visit on (b)(6) 2015, the patient reported sharp pain with a pain level of 4/10 at rest following a 24 hr dance marathon.The patient was given an injection of kenalog.On (b)(6) 2015, the patient reported the pain level had increased to 6/10 at rest.However, the patients medial joint line pain had improved to 1/10.This pain was believed to be related to a ruptured baker's cyst.On (b)(6) 2015, the patient reported a knee pain level of 3/10 and was given another knee injection of kenalog.On (b)(6) 2016, the patient reported a knee pain level of 8/10 and was given another kenalog injection.On (b)(6) 2016, the patient reported continued knee pain at a level of 7/10 without lasting pain relief from the prior knee injections.Dr.(b)(6) stated that the patients degenerative arthritis process was continuing to progress and recommended evaluation for a unicompartmental or total knee replacement.The patient was evaluated by dr.(b)(6) on (b)(6) 2016 and elected to undergo unicompartmental knee replacement on (b)(6) 2016.Dr.(b)(6) performed the unicompartmental knee replacement without any report of complications or the use of bone grafts, augments or special bone cuts.At 2 and 6 weeks after surgery, the patient was reported as doing well and had returned to work.Dr.(b)(6) reported the degenerative arthritis progressing to a unicompartmental knee replacement as an adverse event as part of the observational cohort clinical study.Dr.(b)(6) assessed the event as not related to the device or the procedure.Not returned.

Event Description

Right knee medial compartment unicompartmental arthroplasty procedure (b)(6) 2016.

• Brand Name: ACCUFILL 5CC
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: victor krone ; 841 springdale drive; exton, PA 19341 ; 4848794224
• MDR Report Key: 5983842
• MDR Text Key: 55833115
• Report Number: 3008812173-2016-00019
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 201.050
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 95