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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SHELL; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. G7 SHELL; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Difficult To Position (1467)
Patient Problem No Code Available (3191)
Event Date 05/18/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Medical devices: item number: 110010262, item name: g7 multihole shell, lot #: 6243619, item number: 010000847, item name: g7 liner, lot #: 6108986, item number: 51-149080, item name: taperloc stem, lot #: 3892043, item number: 010000999, item name: g7 screw, lot #: 6025553.Foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04022, 0001825034 - 2018 - 04023, 0001825034 - 2018 - 04024.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the liner would not seat with the acetabular shell.Shell and liner were removed and replaced.Surgery was delayed by approximately 1-2 hours.Attempts have been made and no additional information is available.
 
Manufacturer Narrative
(b)(4).Complaint sample was evaluated and the reported event was not confirmed.The returned product was evaluated against the complaint.The liner and 3hole shell were assembled upon receipt.The flush profile of the liner and 3 hole assembly implies that the liner is fully seated.The liner could not be removed by hand.No motion of any kind was felt or observed during the attempts to remove the liner from the shell.Indentations and scratches were found on the liner's rim.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 available at the time of this report.
 
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Brand Name
G7 SHELL
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 Key7603602
MDR Text Key111136985
Report Number0001825034-2018-04021
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK140669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberN/A
Device Catalogue Number110010242
Device Lot Number6250495
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/18/2018
Initial Date FDA Received06/14/2018
Supplement Dates Manufacturer Received01/16/2019
Supplement Dates FDA Received01/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2018
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) Required Intervention;
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