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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 42MM E; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 42MM E; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Fall (1848); Joint Dislocation (2374)
Event Date 05/05/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: medical devices: catalog number: 650-1158; lot number: 3044051; brand name: delta cer fem hd 28/0mm.Catalog number: 11-304310; lot number: 818290, brand name: arcos 10x260mm brch body.Catalog number:00625006540; lot number:65094425; brand name: bone screw self-tapping.Catalog number:110031011; lot number: 65254557; brand name: 28 mm bearing.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 patient was revised due to dislocation after a fall approximately 2 months post implantation.Additional information on the reported event is unavailable.
 
Manufacturer Narrative
Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.Event is no longer considered reportable, and initial report should be voided.
 
Event Description
Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.Event is no longer considered reportable, and initial report should be voided.
 
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Brand Name
G7 DUAL MOBILITY LINER 42MM E
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key14499154
MDR Text Key293074803
Report Number0001825034-2022-01291
Device Sequence Number1
Product Code KWY
UDI-Device Identifier00880304703513
UDI-Public(01)00880304703513(17)310630(10)883140
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150522
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number110024463
Device Lot Number883140
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2021
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
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age61 YR
Patient SexMale
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