MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM MOD HD STD NECK TP1 TAPER; PROSTHETIC, HIP

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00748.

Event Description

It was reported that the case took place, it was a partial hip due to a femoral neck fracture.Everything went as planned and the case was a success.Three weeks later, the patient was brought back due to an infection.The surgeon washed out the infected hip and replaced the femoral head with a new implant.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001825034-2021-00799.

Event Description

Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number: 0001825034-2021-00799.

• Brand Name: 28MM MOD HD STD NECK TP1 TAPER
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11483356
• MDR Text Key: 239740293
• Report Number: 0001825034-2021-00749
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: K942479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

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
• Device Catalogue Number: 163662
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention