MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 28MM A; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products : unknown-unknown shell-unknown, unknown-unknown head-unknown , unknown-unknown stem-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01149.Report source: (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.

Event Description

It was reported that during a hip arthroplasty the e1 liner would not assemble with the g7 acetabular shell.The surgery was finished with backup product.There was a delay no longer than 15 minutes to prepare backups.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information on reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by visual inspection of product by the product surveillance team.Visual inspection identified scratches on the rim and sidewall, with an indentation on the scallop.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot 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.

• Brand Name: G7 HI-WALL E1 LINER 28MM A
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9847705
• MDR Text Key: 200857221
• Report Number: 0001825034-2020-01148
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 010000913
• Device Lot Number: 6603831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 05/19/2020
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1