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

Device Problem Separation Failure (2547)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) reviewed was unable to be performed as the lot number of the device involved in the event is unknown.Root cause is unable to be determined as the necessary information to adequately investigate the reported event was not 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

It was reported that the during a hip revision surgery the inserter handle would not disengage from the stem, as the surgeon attempted to loosen the handle the inner shaft broke free from the stem leaving the threaded tip of the inserter inside the stem.Subsequently, the patient retained the foreign object.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN STEM
• 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: 10044097
• MDR Text Key: 190553232
• Report Number: 0001825034-2020-01956
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/11/2020
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 67