MAUDE Adverse Event Report: ZIMMER, INC. M/L TAPER KINECTIV STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Swelling (2091); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unknown head.Unknown liner.Unknown cup.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-06089, 0001822565-2017-06087, 0001822565-2017-06091.

Event Description

It was reported that a patient developed deep vein thrombosis (dvt) after being discharged from a total hip arthroplasty.It was noted that after severe swelling the physician ordered an ultrasound which revealed deep vein thrombosis in the calf.The patient experienced further complications related to prescribed medication for the dvt, resulting in a wound hematoma.No products were revised during this procedure.Attempts have been made and no further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: unknown longevity liner catalog#: ni lot#: ni; unknown trilogy cup catalog#: ni lot#: ni; modular neck j2 12/14 neck taper use with +0 heads only catalog#: 00784804301 lot#: ni; unknown biolox head catalog#: ni lot#: ni.Reported event was confirmed through review of medical records.Device history record 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.

Event Description

It was reported that a patient developed deep vein thrombosis (dvt) after being discharged from a total hip arthroplasty.It was noted that after severe swelling the physician ordered an ultrasound which revealed deep vein thrombosis in the calf.The patient experienced further complications related to prescribed medication for the dvt, resulting in a wound hematoma.The patient was brought back to the operating room and the wound hematoma was evacuated.No products were revised during this procedure.Attempts have been made and no further information is available at this time.

• Brand Name: M/L TAPER KINECTIV 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: 6845489
• MDR Text Key: 85003611
• Report Number: 0001822565-2017-06090
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

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
• Device Catalogue Number: 00771301200
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 12/22/2017
• 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): Other; Required Intervention
• Patient Age: 70 YR