MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ARTICULAR SURFACE; IMPLANT, KNEE

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Osteolysis (2377)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

Product identification is unknown.Concomitant medical products: item name: primary stem tibia size 4 left , catalog number: 6307-00-240, lot number: 1385732.Item name: cust nkii prim por fem size 4, left.Catalog number: 6212-00-040, lot number: 1574739.

Event Description

It was reported the patient was revised for diaphysis femoral shaft fracture with extensive osteolytic lesion.

Manufacturer Narrative

Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.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.

• Brand Name: UNKNOWN ARTICULAR SURFACE
• Type of Device: IMPLANT, 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: 6221843
• MDR Text Key: 63845270
• Report Number: 0001822565-2017-00017
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention