MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC.

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The investigation of this issue is still in-process.A supplement to this medwatch will be sent once more information becomes available.

Event Description

Dr (b)(6) via email has reported that his colleague has had a patient that is possibly experiencing an allergic reaction to accufill.

Manufacturer Narrative

3008812173-2017-0013-1, is a duplicate to this complaint but was not identified as a duplicate until after the investigation was completed.Since both complaints contain medwatch forms, they cannot be voided.A supplement report will be sent to fda to explain the duplicate record(s).This is the investigation for 3008812173-2017-0013-1 added to this complaint.Copy of the post-op report of the revision surgery was reviewed and the attending surgeon, dr.(b)(6), was interviewed.The patient had fracture of the navicular with indicating lesion present in the mri.The surgeon treated the lesion with the subchondroplasty procedure on (b)(6) 2016 - injecting less than 1cc of the material into the navicular.The surgeon stated that xray imaging during the surgery confirmed that most of the navicular bone was filled with the injection.Following surgery the patient did obtain some initial relief and improvement but then over time experienced increasing pain in the area.Ct scan and x-ray showed a cyst in the treated area.The second revision surgery was conducted on (b)(6) 2017.The area was exposed to confirm the presence of cyst in the navicular bone.It was also confirmed that there was unstable fracture through the bone in this area.The cyst area was drained and debrided - there was a yellowish fluid found in the cyst area.The bone was then packed with bone graft and secured the fracture with two 4mm fixation screws.The cause of the cyst was unable to be determined.The revision surgery was completed and the patient is non-weight bearing for the treated area during recovery.The dhr lot record of the implant product was reviewed.No reports of non-conformance were found.The report included ftir product testing to confirm correct chemical composition of the material as well as endotoxin testing that reported material conforming to acceptance specifications.

Event Description

Surgeon reported a possible allergic reaction to accufill.

• 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: shari bailey ; 841 springdale drive; exton, PA 19341 ; 4848794543
• MDR Report Key: 6431365
• MDR Text Key: 70767275
• Report Number: 3008812173-2017-00012
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• 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: 08/02/2017

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
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: 02/21/2017
• Supplement Dates FDA Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other