MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 54MM I; PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Adhesion(s) (1695); Scar Tissue (2060); Joint Dislocation (2374); Patient Problem/Medical Problem (2688)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet biolox head cat#12-115109 lot#2886313, biomet bearing cat#ep-200160 lot#211710, biomet g7 cup cat#110010271 lot#3983154, biomet stem cat#11-301300 lot#946930, biomet taper cat#11-300920 lot#013480.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 02362, 0001825034 - 2019 - 02364.

Event Description

It was reported patient underwent right hip revision approximately 1 year post tha.It was reported during an office visit approximately 1 year later, that the patient sustained multiple dislocations and was recently reduced in the emergency department.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Operative notes were provided.Review of the notes demonstrated subfascial adhesions due to previous incisions, reddish synovial fluid noted (unremarkable), adductor tenotomy performed due to limited range of motion per patient anatomy, no intraop complications noted.Additional information does not change the previous summery.

Event Description

It was reported patient underwent an initial right total hip arthroplasty on an unknown date with unknown product.The patient was revised to an arcos revision system approximately 1 year later.Subsequently, it was noted during an office visit approximately 1 year later, the patient sustained multiple dislocations and was reduced in the emergency department.It was further reported that during the reduction, the g7 bearing disassociated from the biolox head.This led to a second revision of the right hip.Patient instructed to continue physical therapy but avoid the motions that cause dislocation.No further event information available at the time of this report.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi# (b)(4).Reported event was confirmed with medical records and x rays.Product was returned.Upon visual inspection the outside diameter of the baring shows circular marks that can be felt with your finger.The head shows scuffing and wear.There are visible scuff marks on the inside diameter of the liner along with two burrs on the lip.Review of the device history records identified no deviations or anomalies during manufacturing.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.

• Brand Name: G7 DUAL MOBILITY LINER 54MM I
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8653518
• MDR Text Key: 146476635
• Report Number: 0001825034-2019-02363
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K150522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• 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: 110024467
• Device Lot Number: 058910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2019
• 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 Weight: 84