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

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Debris, Bone Shedding (1803); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) 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.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under possible adverse effects: under possible adverse effects: material sensitivity reactions.(b)(4).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.(b)(4).This report is being submitted late as it has been identified in remediation.Product location unknown.

Event Description

Information was received based on review of a journal article entitled, "mean 5-year clinical and radiographic outcomes of cement less total hip arthroplasty in patients under the age of 30".One patient was identified in the article requiring a revision due to metallosis and debris.No loosening identified and patient was revised to metal on polyethylene.There has been no further information provided and the patient outcome is unknown.Attempts have been made and no further information has been provided.

• 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: 6941517
• MDR Text Key: 89241744
• Report Number: 0001825034-2017-08479
• Device Sequence Number: 1
• Product Code: KWY
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN HIP
• Device Lot Number: UNKNOWN LOT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention