MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE G 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign source: (b)(6).The product has been 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 when opening the implant during the procedure, it was noticed that the incorrect product was in the box.The bearing was a mobile bearing and not a fixed bearing as the package indicated.There is no additional information at this time.

Manufacturer Narrative

The reported event cannot be confirmed.Product was returned and visual evaluation of the returned product identified that it is a mobile articular surface and lot number on it is conforming to mobile articular surface lot.No packaging/labeling has been returned.The complaint could not be confirmed.The reported event did not occur as part of a medical procedure; medical records are not available for review.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.The product was likely conforming when it left zimmer biomet control.A definitive root cause cannot be determined.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 G 10 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9075075
• MDR Text Key: 159193071
• Report Number: 0001822565-2019-04033
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00889024429536
• UDI-Public: (01)00889024429536
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

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: 00594607010
• Device Lot Number: 64142668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1