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

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Swelling (2091); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Journal article: waterson, h.B., whitehouse, m.R., greidanus, n.V., garbuz, d.S., masri, b.Z., duncan, c.P.(2018).Revision for adverse local tissue reaction following metal-on-polyethylene total hip arthroplasty is associated with a high risk of early major complications, the british editorial society of bone & joint surgery.100-b:720¿4.Https://doi.Org/10.1302/0301-620x.100b6.Bjj-2017-1466.R1.Concomitant medical products: item# unknown unknown stem lot# unknown, item# unknown unknown liner lot# unknown, item# unknown unknown cup lot# unknown.Foreign source-(b)(6).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.

Event Description

It was reported in journal article that patient underwent total hip arthroplasty on an unknown date.Patient underwent revision due to anterior swelling, in vivo implant corrosion, and altr.Attempts were made to obtain additional information; however, none was available.Anterior swelling and proceeded with revision of tha.

Manufacturer Narrative

Cmp-(b)(4).This report is being submitted to relay additional information.The following sections were updated: reported event was unable to be confirmed due to limited information provided.Device history record (dhr) review was unable to be performed as the lot number was not provided.Root cause could not be determined with the information 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

No further event information available at the time of this report.

• Brand Name: UNKNOWN HEAD
• 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: 7903272
• MDR Text Key: 121561950
• Report Number: 0001822565-2018-05160
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention