MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY SHELL WITH HOLES; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product location is unknown.

Event Description

It was reported that the liner could not be fixed into the shell because vinyl pieces (inner packaging) were attached to the shell.After removal of vinyl pieces the liner was fixed into the shell.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Additional: type of reportable event, if follow-up, what type, device evaluated by mfr, and evaluation codes.Udi: (b)(4).Reported event was confirmed by review of pictures and the two debris pieces were returned.However, the product and packaging were not returned for evaluation.The two returned vinyl fragments were confirmed to have a foreign substance on them.Dhr was reviewed and no discrepancies were found.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

No further event information available at the time of this report.

• Brand Name: TRILOGY SHELL WITH HOLES
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7326523
• MDR Text Key: 101987658
• Report Number: 0001822565-2018-01305
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: PK980711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 65620005420
• Device Lot Number: 63558105
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1