MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL NC 18X170MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown-unk broach- 595880.X31-400038-exact alliance tpr rmr 18mm-239510.110010246-g7 osseoti 4 hole shell 56mm f-6528677.30124006-g7 vit e high wall lnr 40mm f-64552361.010001036-cocr fem hd 40mm type1 -3mm-6553180.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during an initial hip procedure that the femoral stem would not seat properly with the broach.During the procedure the surgeon chose to use -3 head from the original std head.Stem was implanted and sat proud.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 unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.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 additional information on the reported event.

• Brand Name: ECHO POR FMRL NC 18X170MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10611969
• MDR Text Key: 209351842
• Report Number: 0001825034-2020-03666
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00887868260490
• UDI-Public: (01)00887868260490
• Combination Product (y/n): N
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• 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: 192018
• Device Lot Number: 851990
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Age: 64 YR