MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UKNOWN CUP; PROSTESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Osteolysis (2377)

Event Date 09/13/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reportable event was unable to be confirmed due to limited information received from customer.Device history record (dhr) review was unable to performed as the lot number of the devise involved in the event is unknown, root cause was unable to determined.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.Concomitant medical products: part # unknown/ unknown head/ lot # unknown, part # unknown/ unknown stem/ lot # unknown, part # unknown/ unknown cup/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 - 04810, 0001825034 - 2019 -04812.

Event Description

It was reported patient underwent r hip revision on unknown date due to swelling, inflammation, tissue and bone damage.Head, cup and stem were removed.Attempts have been made and no further information has been provided.

• Brand Name: UKNOWN CUP
• Type of Device: PROSTESIS, 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: 9223991
• MDR Text Key: 163594000
• Report Number: 0001825034-2019-04811
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/22/2019

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 10/23/2019
• 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): Life Threatening; Required Intervention