MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 10 DEG E1 LINER 32MM B; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Date 10/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Concomitant medical products: catalog number:010000885 lot number:6509413 brand name:g7 10 deg e1 liner 32mm b.Catalog number:010000885 lot number:6489091 brand name:g7 10 deg e1 liner 32mm b.Catalog number:010000660 lot number:6593997 brand name:g7 pps ltd acet shell 46b.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03859.0001825034-2020-03861.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 an initial cup arthroplasty, the liner would not assemble into the cup.A second liner was used and it also would not assemble with the cup.This lead the surgeon to try hard to insert which resulted in acetabulum fracture.The surgery was completed with an alternative larger cup and liner with a 2 hours delay.Additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Two liners and one shell were returned and evaluated.Upon visual inspection the liners have some scuffing to the outside radius and the locking feature.The shell has no visible damage to the device.The liners fit the shell with the scallops in location however the devices were not pressed together into a locked position.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.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.

Event Description

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

• Brand Name: G7 10 DEG E1 LINER 32MM B
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10733618
• MDR Text Key: 213001266
• Report Number: 0001825034-2020-03860
• Device Sequence Number: 1
• Product Code: JDI
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000885
• Device Lot Number: 6489091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other