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

Model Number N/A

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: argentina.Concomitant medical products: 11-103206-taperloc por lat fmrl 12.5x145-939270; 010000666-g7 pps ltd acet shell 58g-6883595; 010000998-g7 screw 6.5mm x 25mm-6861266; 650-0661-delta ceramic fem hd 36/0mm-3062817.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown at this time.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a hip revision approximately 1-year post implantation due to a sudden development of noise and pain.Patient went to er where an x-ray confirmed the fractured head.During the revision, a multi-fragmented fractured head was discovered.The center of the liner was found to be worn and friction scratches on the trunnion cone of the stem were noted.Liner and head exchanged.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported it was reported patient underwent a hip revision approximately 1-year post implantation due to a sudden development of noise and pain.The patient was doing well until one day when he was kneeling with his hip slightly extended when he heard a noise in the hip followed by discomfort with a creaking sound.Upon radiographic review, the ceramic head was noted to be broken with impaction of the stem into the poly.During the procedure friction scratches were noted on the stem trunnion and wear noted on the liner center with marks made by the impacted cone in addition to the ceramic head found to be in multiple pieces.The stem and cup were well fixed and left in place.The head and liner were replaced without complication.No additional information available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed via medical records and radiographs reviewed by a health care professional.Visual examination of the provided pictures identified show the ceramic head fractured as reported with the liner still seated in the shell.A review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause cannot be determined for the head fracture, however it can be noted that the wear to the stem and liner are more than likely secondary to the head fracture.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 additional information on the reported event.

• Brand Name: G7 NEUTRAL ARCOMXL LNR 36MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15160406
• MDR Text Key: 297191749
• Report Number: 0001825034-2022-01792
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524996
• UDI-Public: (01)00880304524996(17)240922(10)6628991
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000742
• Device Lot Number: 6628991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 102 KG