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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034-2018-04303.0001825034 - 2018 - 04302.Reported event was confirmed via x-ray report.Review of provided patient x-rays confirms the reported implant dislocation as well as varus positioning of the femoral stem.Review of device history records was not possible as the necessary product/lot code combination(s) was not provided.Root cause was unable to be determined due to limited information received from the customer.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.Not returned to manufacturer.

Event Description

It was reported the patient received multiple closed reductions to address chronic lateral femoral head dislocation from the acetabular construct.The implants remain in-vivo and no revision has been scheduled to date.No further information is available at this time.

• Brand Name: UNKNOWN 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: 7869221
• MDR Text Key: 119975172
• Report Number: 0001825034-2018-08817
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 09/12/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 09/12/2018
• 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, LINER, HEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR