MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN VERSYS FULLY POROUS-COATED FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date article was accepted.Concomitant medical products- unknown trilogy modular trabecular metal shell, unknown longevity highly cross-linked polyethylene liner, unknown femoral head; therapy date unknown.Abdel, m.P., chalmers, b.P., trousdale, r.T., hanssen, a.D., & pagnano, m.W.(2017).Randomized clinical trial of 2-incision vs mini-posterior total hip arthroplasty: differences persist at 10 years.The journal of arthroplasty.Doi:10.1016/j.Arth.2017.04.005.No devices or photos of the devices were received; therefore, the condition of the components is unknown.Additionally, visual and dimensional evaluations could not be performed.The product number and the lot number were not provided; therefore, the manufacturing date, the device history records and the field age of the device could not be determined.There is insufficient information to perform a complaint history search.A definitive root cause could not 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-03734, 0001822565-2017-03735, 0001822565-2017-03736.

Event Description

It was reported that patient experienced acute deep venous thrombosis post-implantation.The patient was treated with anticoagulants and did not experience long term sequelae.Attempts have been made and no further information is available.

• Brand Name: UNKNOWN VERSYS FULLY POROUS-COATED FEMORAL STEM
• Type of Device: PROSTHESIS, HIP
• 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: 6605263
• MDR Text Key: 76443922
• Report Number: 0001822565-2017-03731
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2017

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/01/2017
• 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): Life Threatening; Required Intervention