MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. CPLT F&A KIT 3CC 15G END; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent scp with an antegrade approach to inject the left calcaneum with 0.6cc of accufill reconstituted in saline.Concomitant procedures included a left peroneus brevis tendon repair, synovectomy, and hardware removal.The patient was treated for a 1-inch superficial non-healing wound with debridement in the clinic.The investigator labeled the event as possibly related to the surgical procedure, not related to the implant, and moderate in intensity.The event has been resolved.

Event Description

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further event information available at the time of this report.

• Brand Name: CPLT F&A KIT 3CC 15G END
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 10677200
• MDR Text Key: 211254420
• Report Number: 3008812173-2020-00020
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00889024205352
• UDI-Public: (01)00889024205352(17)221111(10)KC06405
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: N/A
• Device Catalogue Number: 514.315
• Device Lot Number: KC06405
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 10/19/2020; 10/29/2020
• Supplement Dates FDA Received: 10/21/2020; 11/03/2020
• 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: 38 YR
• Patient Weight: 94