MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 32MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 is not being returned.

Event Description

It was reported that the liner was put into the shell, but could not be fixed to the shell.This surgery was finished with back-up liner.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.One g7 hi-wall e1 liner 32mm f was returned and evaluated.Visual inspection of the liner doesn¿t show any damage to the outer radius or the locking feature.The scallops have some visible damages to the likely caused during an attempt to insert the liner into the cup and during removal.Review of the device history records for the liner identified no related deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause could not 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: G7 HI-WALL E1 LINER 32MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8237155
• MDR Text Key: 132852826
• Report Number: 0001825034-2019-00142
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• 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: 010000928
• Device Lot Number: 3347090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1