MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. CPLT F&A KIT 3CC 11G END; SCP KIT

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020, a patient underwent a subchondroplasty procedure in an antegrade approach on their right talus.The talus was injected with 1.0 cc accufill reconstituted with saline.It is unknown at this time if concomitant procedures were performed.The patient does have a medical history of gout.On (b)(6) 2020, the patient was hospitalized for increased pain and administration of pain medication.The health care professional determined the event was definitely related to the procedure and possible related to the implant.The redacted operative notes were provided for the investigation.Once additional information about the event becomes available, an additional report will be submitted.

Event Description

Subject 12-024 suffers severe ankle pain after scp f&a study.

Manufacturer Narrative

Clinical subject (b)(6) underwent the initial subcondroplasty procedure on (b)(6) 2020, and approximately 1mm of accufill reconstituted with saline was injected into the talus, which is according to the surgical technique.The operative notes were requested and provided for the investigation.A right ankle arthroscopy with extensive debridement, right talus body orif, right peroneal tendon repair, and right talus fracture, orif of the posterolateral process, and right distal tibia orif were performed concomitantly.There were no intraoperative complications reported, and the patient left the operating room in stable conditions.The patient was provided postoperative medication and instructions to remain strictly non-weight bearing on their right lower extremity.The patient was instructed to return for xray images within two weeks.The baseline pain score for the patient was identified as a 10/10 and they have a history of gout and other concomitant issues.On (b)(6) 2020 patient was re-hospitalized with extreme pain of the treated foot and ankle and was given oxycodone, hydromorphine, valium, lyria, and hydromorphone iv for the pain.It is not uncommon for a patient to experience pain for up to 2-3 weeks after surgical injection due to the invasive nature of the surgery.There is no information available outside of the clinical adverse event report which states that the procedure is not directly related to the complaint incident but could possibly be related.There is no further information to determine if the surgical pain had normally resolved after time or not.The nature of this complaint and cause is indeterminate.The product was not returned for the investigation, as it remains implanted in the patient.The dhr for the finished goods lots were reviewed, and no anomalies related to the complaint condition were noted.

Event Description

Subject (b)(6) suffers severe ankle pain after scp f&a study.

• Brand Name: CPLT F&A KIT 3CC 11G END
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9728696
• MDR Text Key: 187431666
• Report Number: 3008812173-2020-00006
• 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
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: N/A
• Device Catalogue Number: 514.303
• Device Lot Number: KC06404
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2020
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/30/2020
• 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: 41 YR
• Patient Weight: 86