MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE 1 8 MM HEIGHT FEMORAL; PROSTHESIS KNEE

Model Number N/A

Device Problems Difficult to Insert (1316); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: catalog #: 00584200101, tibial component precoat left medial/right, lot # 63797666; catalog #: 00584201301, femoral component high flex precoat, lot # 63943899.(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.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.Will be returned.

Event Description

It was reported that it was impossible for surgeon to insert the articular surface into the tibial plate.A same-sized new surface was used to complete the surgery.

Manufacturer Narrative

(b)(4).Reported event was considered confirmed as visual examination shows nicks and gouges on the device.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 1 8 MM HEIGHT FEMORAL
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8355336
• MDR Text Key: 136767409
• Report Number: 0001822565-2019-00747
• Device Sequence Number: 1
• Product Code: HSX
• 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: 09/27/2019

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: 00584202108
• Device Lot Number: 63626197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1