MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE PROVISIONAL SIZE GH; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.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

It was reported that during routine trialing, the provisional broke in half.

Event Description

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

Manufacturer Narrative

(b)(4).Report source: (b)(6).Reported event was confirmed by review of actual device received.Visual examination of the returned part indicates that the device exhibits signs of repeated use (niced or gouged) and was fractured.Dimensional examination indicates that the device conforms to the measurable print specifications.Device history record (dhr) was reviewed with no deviations identified.The product had a possible field life of over 10 years and shows heavy signs of wear, therefore root cause was determined to be wear and tear over a successful field life.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: ARTICULAR SURFACE PROVISIONAL SIZE GH
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7615047
• MDR Text Key: 111688062
• Report Number: 0001822565-2018-03319
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• 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: 03/07/2019

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00596105012
• Device Lot Number: 60895865
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 02/18/2019
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1