MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS HMRL TI TRAY 44MM; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This process is assembled in one operation then the ring assembly and function is inspected in the next.Both of these occurred and a survey of the operators/inspectors, that perform this function, concur that it is nearly impossible for this defect to be passed by both tm's.The internal evidence point to an attempt to remove the ring external to biomet.This however cannot be confirmed.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.Root cause was unable to 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

The surgeon opened the humeral tray standard, when the box was open the locking ring inside the tray was bent so he cannot get the humeral bearing on.

• Brand Name: COMP RVS HMRL TI TRAY 44MM
• Type of Device: PROSTHESIS, EXTREMITY
• 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: 6926391
• MDR Text Key: 89941474
• Report Number: 0001825034-2017-08063
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 755410
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2014
• Date Device Manufactured: 09/29/2014
• 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