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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Swelling/ Edema (4577)

Event Date 01/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000665, g7 pps ltd acet shell 56f, 6564116.00877503601, bioloxâ® delta, ceramic head, 2993352.0106010107, avenirâ® stem taper 12/14, 2935433.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent right total hip arthroplasty and experienced a dislocation on approximately three months later post primary implantation and a subsequent dislocation again four days after that.Products remain implanted.No revision has been reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.

Event Description

It was reported that patient underwent right total hip arthroplasty and experienced a dislocation on approximately three months later post primary implantation, a subsequent dislocation again four days after that and then again 2 months later.Products remain implanted.Pain and swelling were reported during the third dislocation.Reduction was completed in the er and the patient was discharged home with knee brace and crunches.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned, and no pictures were provided; however, medical records were provided and reviewed by a health care professional.A review of the available records identified the following: reports two separate dislocations.Right hip recurrent dislocation with pain and swelling, dislocation confirmed via x-ray.The complaint was confirmed based on medical record evaluation.The additional information does not change the outcome of the previous investigation.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 is available at the time of this report.

• Brand Name: G7 NEUTRAL ARCOMXL LNR 36MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10474166
• MDR Text Key: 205071604
• Report Number: 0001825034-2020-03403
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524989
• UDI-Public: (01)00880304524989(17)240704(10)6585839
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• 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: 010000741
• Device Lot Number: 6585839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 82 KG