MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 32MM H; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Dob : unknown month and day in 1957.Concomitant medical products: catalog#: 010000821g7 hi-wall arcomxl lnr 36mm h lot#: 6621357.Catalog#: 110010269 g7 osseoti multihole 62mm h lot#: 6470239.Foreign 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.Multiple mdr reports were filed for this event, please see associated reports: -0001825034-2020-04394.-0001825034-2020-04395.

Event Description

It was reported that during a revision surgery, there were made several attempts to seat a 36mm hi-wall liner with non-satisfactorily result.Another 32mm hi-wall liner was opened but this would not seat either.There was applied a 90 degrees impact with a mallet and several hard blows was attempted at each try.During the attempts to seat the liner, the patient sustained an acetabular fracture that was treated conservatively.Surgery was completed with a tmt modular cup and a 10 degree liner.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

The event was confirmed with product received.Visual inspection found pitting on the outer radius of the liner.The outer radius and sidewall are also scratched.Device history record was reviewed and no discrepancies relevant to the reported event 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.

Event Description

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

• Brand Name: G7 HI-WALL ARCOMXL LNR 32MM H
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11080372
• MDR Text Key: 224248284
• Report Number: 0001825034-2020-04393
• 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: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000813
• Device Lot Number: 6455611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 72