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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 HI-WALL E1 LINER 32MM E; PROSTHESIS, HIP
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BIOMET ORTHOPEDICS G7 HI-WALL E1 LINER 32MM E; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009)
Patient Problem No Information (3190)
Event Date 04/13/2016
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, nonunion, bone resorption, and/or excessive, unusual and/or awkward movement and/or activity." under warnings, "improper selection, placement, positioning, alignment and/or fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.".
 
Event Description
Patient underwent a right hip revision procedure two days post-implantation due to disassociation of the liner.The liner and head were removed and replaced.The liner was reported to have been not fully inserted during the initial procedure.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
 
Event Description
Patient underwent a right hip revision procedure two days post-implantation due to disassociation of the liner.The liner and head were removed and replaced.The liner was reported to have been not fully inserted during the initial procedure.It was also reported that the patient's weight may have been a contributing factor, as exposure was more difficult.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products - g7 acetabular cup catalog#: 010000703 lot#: 3702719, ceramic femoral head catalog#: 650-1162 lot#: 2016010382, femoral stem catalog#: 51-117150 lot#: 3222243.It has been indicated that the product will not be returned to zimmer biomet, as its location is unknown.Dhr was reviewed and no discrepancies were found.The reported event was unable to be confirmed due to limited information received from the customer.The root cause was unable to be determined, as the device was not returned for evaluation if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will contribute to monitor for trends.
 
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Brand Name
G7 HI-WALL E1 LINER 32MM E
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key5697607
MDR Text Key46502495
Report Number0001825034-2016-01933
Device Sequence Number1
Product Code PBI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PK121874
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date06/30/2020
Device Model NumberN/A
Device Catalogue Number010000927
Device Lot Number3585146
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age45 YR
Patient Weight81
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