Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 ACETABULAR LINER NEUTRAL E1 32MM SIZE D; PROSTHESIS, HIP
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET ORTHOPEDICS G7 ACETABULAR LINER NEUTRAL E1 32MM SIZE D; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 08/17/2016
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: 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
It was reported that a during a total hip arthroplasty procedure, the surgeon had difficultly inserting the liner.The surgeon was able to complete the procedure using another liner.It is unknown if there was a delay.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).
 
Manufacturer Narrative
This follow up report is being submitted to relay corrected and additional information.Medical devices: part: 110010243 name: g7 osseoti 3 hole shell lot: 3807494.Complaint sample was evaluated and the reported event could not be confirmed.Visual inspection of the liner revealed damage from attempted implantation and removal.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.There are warnings in the package insert that this type of event can occur and associated risks are addressed in risk documentation.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
It was reported that a during a total hip arthroplasty procedure, the surgeon had difficultly inserting the liner.The surgeon was able to complete the procedure using another liner without patient injury or a significant delay.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
G7 ACETABULAR LINER NEUTRAL E1 32MM SIZE D
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 Key5950808
MDR Text Key54749453
Report Number0001825034-2016-03631
Device Sequence Number1
Product Code PBI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK121874
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 07/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date06/08/2021
Device Model NumberN/A
Device Catalogue Number010000848
Device Lot Number3814621
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/17/2016
Initial Date FDA Received09/14/2016
Supplement Dates Manufacturer ReceivedNot provided
06/29/2017
Supplement Dates FDA Received10/17/2016
07/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2016
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
-
-