MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 05/21/2020

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.

Event Description

It was reported the taperloc/ for oa, primary procedure.Acetabulum was prepared for a 54mm clusterhole cup using a 45- 55mm reamers.Cup was impacted and a 36mm / f high wall vit e poly liner was impacted with a 36mm impactor as per surgical technique.The liner could not be seated and after 6 attempts it was decided to open a new liner.However, as a 36mm liner was not available so a 32mm/f high wall liner was used.No adverse events were reported due to this malfunction.No additional information is available at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; h2; h3; h4; h6.Reported event was confirmed with medical records provided.Review of the available records identified the following: the 36mm poly was unstable/dislocating and would not stay seated.Since another 36mm liner was not available, a 32mm liner used.There was a 20 min delay / added surgery time.No impact to patient.Visual examination of the provided pictures identified the liner is laying on a cloth/towel.No other information can be obtained from the picture.Review of the device history records identified no deviations or anomalies during manufacturing.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 36MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10156140
• MDR Text Key: 195263376
• Report Number: 0001825034-2020-02223
• 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: 07/20/2020

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: 010000936
• Device Lot Number: 6687380
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 07/17/2020
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET G7 SHELL CAT#010000704 LOT#6743008; BIOMET G7 SHELL CAT#010000704 LOT#6743008
• Patient Weight: 58