MAUDE Adverse Event Report: ZIMMER, INC. INTERCHANGEABLE HUMERAL ASSEMBLY SMALL LONG FLANGE 8 INCH LENGTH; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ulnar component, catalog#: 32810509301, lot#: 60171749.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the patient underwent a revision procedure due to the locking pin coming out.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.X-ray reviewer stated the following about the x-rays "ap x-ray of the elbow shows loosening of the locking pin which has backed out slightly since the earlier exam." 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 SMALL LONG FLANGE 8 INCH LENGTH
• Type of Device: PROSTHESIS, EXTREMITY
• 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: 6847530
• MDR Text Key: 85080411
• Report Number: 0001822565-2017-06302
• 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: distributor,health profession
• 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: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 32810503508
• Device Lot Number: 61485919
• Other Device ID Number: N/A
• 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: 06/04/2010
• Is the Device Single Use?: Yes
• 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