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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 38MM C PROSTHESIS HIP

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ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 38MM C PROSTHESIS HIP Back to Search Results
Catalog Number 110024461
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2021
Event Type  malfunction  
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. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item #110026852/g7 hard bearing inst ring sz c/ lot # unknown.
 
Event Description
It was reported that during an initial hip procedure the surgeon successfully implanted the cup. The inserter ring was then place on the liner and was ready for impaction. Upon impaction the inserter ring fractured causing the liner to not seat correctly in the cup. The surgeon then removed the liner with an instrument that caused damage to the metal liner. He then requested another liner and a second dual mobility tray for another inserter ring. The second liner was successfully impacted and the surgery was completed. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameG7 DUAL MOBILITY LINER 38MM C
Type of DevicePROSTHESIS 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 Key11862045
MDR Text Key251924049
Report Number0001822565-2021-01366
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K150522
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 05/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number110024461
Device Lot Number638880
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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