MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL ARCOMXL LNR 36MM H; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 09/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 010000668, g7 ,pps, ltd, acet, shell, 62h, lot: 3807464.Part: 010000743, g7, neutral, arcomxl, lnr, 36mm, h, lot: 6375903.Part: 010000998, g7, acetabular, screw, 6.5 x 25 mm, lot: 6465835.Part: 010000998, g7, acetabular, screw, 6.5 x 25 mm, lot: 6242427.Part: 650-1057, 36, head, ceramic, lot: 2958835.Part: 193013, echo, bimetric, microplasty, hip, stem, lot: 647390.Part: 650-1066, taper, adapter, type, i, lot: 2959105.Multiple mdr reports were filed for this event, please see associated reports: cup: 0001825034-2019-04738, liner: 0001825034-2019-04737.

Event Description

It was reported that during an initial hip arthroplasty the g7 poly would not engage into the g7 shell, another liner was attempted and it would not seat as well.Shell was then removed and the procedure was completed with a second shell and a third liner.A total delay of 2.5 hours was reported.Attempts have been made and no further information has been provided.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was unconfirmed.Upon visual inspection there is no damage to the shell.Both of the returned liners showed scuffing on the outside diameter and damage to the locking feature that could have caused event.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.A summary of the investigation has been sent to the complainant by email.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 NEUTRAL ARCOMXL LNR 36MM H
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9208367
• MDR Text Key: 201058006
• Report Number: 0001825034-2019-04736
• Device Sequence Number: 1
• Product Code: LPH
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000743
• Device Lot Number: 6238012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 108