MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE F 9 MM THICKNESS DO NOT IMPLANT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 06/28/2019

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.

Event Description

It was reported that during a partial knee arthroplasty the provisional tibial bearing was damaged.No patient consequence was reported.No additional information is available.

Event Description

No additional information received.

Manufacturer Narrative

Udi# (b)(4).

Event Description

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

Manufacturer Narrative

The reported event was able to be confirmed by examination of the suspect device.Visual examination of the returned provisional device showed signs of repeated use and was fractured and worn.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause was unable to 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.

• Brand Name: ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE F 9 MM THICKNESS DO NOT IMPLANT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8816892
• MDR Text Key: 151892029
• Report Number: 0001825034-2019-03176
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2020

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: 42518100609
• Device Lot Number: 63773331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 07/23/2019; 02/06/2020
• Supplement Dates FDA Received: 08/13/2019; 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1