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

Model Number N/A

Device Problems Difficult or Delayed Positioning (1157); Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 07/17/2018

Event Type  Injury  

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.(b)(4).Concomitant medical products: part # 110017104, shell, lot # 6289096; part # 00625006520, screw, lot # 63776537; part # 00625006525, screw, lot # 63793447; part # 650-0661, head, lot # 2017050077; part # 00625006525, screw, lot # 63855357; part # 00625006530, screw, lot # 63905767; part # 51-107100, stem, lot # 6129911.Event occurred in (b)(6).

Event Description

It was reported that during a primary hip surgery, the liner was difficult to seat into the cup, and the surgeon attempted to seat the liner for 45 minutes.The surgeon thus had to open a new liner, and took an additional 10 minutes to impact the liner into the cup.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Upon visual inspection, the liner showed scraping.Two small and light circular marks on the outside diameter of the liner were identified.The scallops of the liner show impaction marks.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined with the information provided.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 ARCOMXL LNR 36MM F
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7771852
• MDR Text Key: 116715006
• Report Number: 0001825034-2018-04731
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000819
• Device Lot Number: 6264664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR