MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER UNICOMPARTMENTAL KNEE SYSTEM - TIBIAL COMPONENT SIZE 4; PROSTHESIS, KNEE

Catalog Number 00584200401

Device Problems Fracture (1260); No Apparent Adverse Event (3189)

Patient Problems Bone Fracture(s) (1870); No Information (3190)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products - unknown femoral component; unknown articular surface.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a revision of a left unicompartmental knee system due to fracture of the tibial component.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

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.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional and corrected information the reported event is confirmed as the x-ray review confirms fracture of the lateral tibial plateau.No products were returned; however, pictures of unicompartmental knee components were provided.The photograph inspection identified foreign material, similar to bone cement, attached to the inferior surface of both the tibial and femoral components.Portion of the bone cement like material attached to the inferior surface of the tibial component broke off along a clean fracture line.Visual inspection of the articular surface picture was unable to be performed with the photograph provided.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Compatibility check was performed with no issues noted.The implant was in-vivo with no issue for 10 years.The fracture of surrounding tissue is a known potential adverse effect of the procedure.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 a patient underwent a revision of a left unicompartmental knee system due to fracture of the tibial plateau.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ZIMMER UNICOMPARTMENTAL KNEE SYSTEM - TIBIAL COMPONENT SIZE 4
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6461163
• MDR Text Key: 71752231
• Report Number: 0001822565-2017-02129
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2017

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: Physician
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 00584200401
• Device Lot Number: 60695971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: 09/19/2017; 11/27/2017
• Supplement Dates FDA Received: 10/12/2017; 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention