MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED TIBIAL COMPONENT PRECOAT SIZE 7; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 12/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign (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.

Event Description

It was reported that a patient had a total knee arthroplasty subsequently three years after the procedure the patient was scheduled for a right knee revision due to malfunctioning.During the implant removal, it was discovered that the tibial tray had fractured.

Manufacturer Narrative

(b)(4).Complaint is confirmed.Visual examination of the provided pictures identified that the tibial is broken.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.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: STEMMED TIBIAL COMPONENT PRECOAT SIZE 7
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11154791
• MDR Text Key: 226263519
• Report Number: 0002648920-2021-00002
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K933785
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598005701
• Device Lot Number: 63628837
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ITEM 00596405014 LOT 63607811; ITEM 00596405014 LOT 63607811
• Patient Outcome(s): Hospitalization; Required Intervention