MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were submitted for this event.Please see report(s): 0001825034 - 2018 - 00525, 0001825034 - 2018 - 00526, 0001825034 - 2018 - 00527.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported patient expired 23 years post primary left hip total hip arthroplasty.No further information is available at this time.

Manufacturer Narrative

Upon reassessment of the event it was determined the known causes of death with this post surgery timeframe are related to infection and mom since these are not mom and post one year implant, we can eliminate our device.The report submitted initially needs to be voided.

• Brand Name: UNKNOWN FEMORAL STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7240688
• MDR Text Key: 98990168
• Report Number: 0001825034-2018-00524
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• 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
• Treatment: UNKNOWN PART/LOT: HEAD, LINER, STEM, CUP
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 68