MAUDE Adverse Event Report: ZIMMER TMT STEM COLLAR 30 MM

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 06/26/2018

Event Type  Injury  

Manufacturer Narrative

Investigation in process.Device not returned.

Event Description

Patient underwent an initial left knee procedure on (b)(6) 2017.Subsequently, the patient was revised due to fracture.Mechanical fall twisting implant failed at tm collar to bone attachment.

• Brand Name: STEM COLLAR 30 MM
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: saurin patel ; 10 pomeroy road; parsippany, NJ 07054 ; 8622611241
• MDR Report Key: 7819674
• MDR Text Key: 118329058
• Report Number: 3005751028-2018-00048
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: PK070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00585204030
• Device Lot Number: 63638827
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2017
• 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): Required Intervention
• Patient Age: 74 YR