MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE EF 9 MM HEIGHT; KNEE PROSTHESIS

Model Number N/A

Device Problem Dent in Material (2526)

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

Event Date 01/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has not indicated that the product will not be returned to zimmer biomet for investigation.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 articular surface was dented during implantation of a primary knee.No additional information is available at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of articular surface identified signs of use (nicked or gouged) and the dovetail feature is flared and compressed.Device history record (dhr) was reviewed and no discrepancies were found.Complaint indicates that the surgical technique was followed; however, the dovetail compression identified during the evaluation of the returned product indicates that the articular surface was not properly aligned being pushed in with the inserter.The root cause is related to the surgical technique.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.

Event Description

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

• Brand Name: ARTICULAR SURFACE SIZE EF 9 MM HEIGHT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8265585
• MDR Text Key: 133772767
• Report Number: 0001822565-2019-00290
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K991581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

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: 00596404009
• Device Lot Number: 64066093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 09/20/2019
• Supplement Dates FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1