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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Foreign Body Reaction (1868); Post Operative Wound Infection (2446)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown, unknown taperloc stem, unknown; unknown, unknown head, unknown; unknown, unknown liner, unknown; therapy date: (b)(6) 2016.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2018 -06067, 0001825034 -2018 -06069, 0001825034 -2018 -06072.

Event Description

It was reported patient presented with drainage from hip approximately 1 month post initial right total hip arthroplasty.Irrigation and debridement was performed.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event confirmed due to medical records received from the customer.No device was returned for evaluation.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.

• Brand Name: UNKNOWN SHELL
• 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: 7752931
• MDR Text Key: 116119552
• Report Number: 0001825034-2018-06070
• Device Sequence Number: 1
• Product Code: JDG
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

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?: No
• 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: 07/12/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/09/2018
• Supplement Dates FDA Received: 08/30/2018
• 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
• Patient Age: 66 YR
• Patient Weight: 117