MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CRUCIATE RETAINING CR-FLEX FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi #: (b)(4).Foreign report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the during total knee arthroplasty it was noted that a dent in the paper which appeared like the seal was broken from the paper to the plastic box in one corner.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h6, h10 visual examination of the returned product found the inner cavity tyvek seal to be conforming.The inner tyvek lid was peeled and the sealing edge bore homogeneous glue remain without any crease or channel.Therefore, the complaint is not confirmed and the product is acceptable.Acceptance criteria [seal adhesive transfer is homogeneous throughout the width of the seal flange].As the packaging was determined to be acceptable.Acceptance criteria [seal adhesive transfer is homogeneous throughout the width of the seal flange].Review of the packaging determined that no failure was found as the product is within specification(s).If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CRUCIATE RETAINING CR-FLEX FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9763583
• MDR Text Key: 189920649
• Report Number: 0001822565-2020-00729
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K041100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 65595201502
• Device Lot Number: 64138338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 104