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

Model Number N/A

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/21/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet as they are probably discarded.The investigation is in process.Once the investigation has been completed a follow up mdr will be submitted.

Event Description

It is reported that patient was revised due to unknown reasons.Attempts have been made and additional information is not available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer, however, review of provided radiograph found radiolucency at the humeral stem which is consistent with loosening and noted the humeral component stem is off-center medially and posteriorly within the humeral canal, with nonuniform cement mantle, which may have contributed to loosening of the humeral component.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.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: INTERCHANGEABLE HUMERAL ASSEMBLY
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6848661
• MDR Text Key: 85134866
• Report Number: 0001822565-2017-06327
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK001989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 32810503506
• Device Lot Number: 60669418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR