MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE HUMERAL ASSEMBLY; PROSTHESIS, EXTREMITY

Catalog Number 32810502704

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient was revised to address aseptic humeral loosening.No further information has been made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record identified no related deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic lucencies/poor integration of the hardware in the distal humeral region is consistent with the concern of loosening.Nonspecific soft tissue swelling a definitive root cause cannot be 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.

Event Description

No further information has been made available at this time.

• Brand Name: INTERCHANGEABLE HUMERAL ASSEMBLY
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8831561
• MDR Text Key: 152348836
• Report Number: 0001822565-2019-03181
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K001989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 32810502704
• Device Lot Number: 62959554
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2019
• 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
• Patient Age: 60 YR