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

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed as part number and lot number of the device involved in the incident is unknown.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.This report is being submitted late as it has been identified in remediation.Bosker, b.H., ettema, h.B., rossum, m.V., boomsma, m.F., kollen, b.J., maas, m., & verheyen, c.C.(2015).Pseudotumor formation and serum ions after large head metal-on-metal stemmed total hip replacement.Risk factors, time course and revisions in 706 hips.Archives of orthopaedic and trauma surgery, 135(3), 417-425.Doi:10.1007/s00402-015-2165-2.

Event Description

Information was received based on review of a journal article titled, "pseudotumor formation and serum ions after large head metal-on-metal stemmed total hip replacement.This article identified post tha the mean cobalt level for an unknown number of patients with pseudotumors was 11.0.There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN HIP
• Type of Device: HIP PROSTHESIS
• 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: 6954498
• MDR Text Key: 89484938
• Report Number: 0001825034-2017-08666
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2015
• 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