MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIPTIGHT AC JOINT 2 ZIPLOOPS TH TEETH; FASTENER, FIXATION

Catalog Number 904835

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi#: (b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded by the hospital as a biohazard.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the implant was loosened a few hours post-surgery.It is unknown if it was due to a malfunction of the implant or a poor post-surgical rehabilitation.No revision has been reported to date.Attempts have been made and no further information has been provided.

Event Description

No additional event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was 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.

• Brand Name: ZIPTIGHT AC JOINT 2 ZIPLOOPS TH TEETH
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10133589
• MDR Text Key: 194675268
• Report Number: 0001825034-2020-02270
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K130033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2023
• Device Catalogue Number: 904835
• Device Lot Number: 005310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention