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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER NEUTRAL 36 MM I.D.; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. LINER NEUTRAL 36 MM I.D.; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Medical Device Problem Code Unstable (1667)
Health Effect - Clinical Code No Information (3190)
Date of Event 10/06/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 00625006530 ¿ bone screw ¿ 64438707; 11-300817 ¿ arcos taper ¿ unknown lot; 11-301111 ¿ arcos stem ¿ 174250; 12-115121 ¿ ceramic head ¿ 2971332; 110010247 ¿ g7 shell ¿ 6627170.Customer has indicated that the product will not be returned to zimmer biomet for the 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.
 
Event or Problem Description
It was reported that patient underwent a hip revision approximately 5 months post implantation due to instability.The head and liner were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event or Problem Description
No further event information available at the time of this report.
 
Additional Manufacturer Narrative
Reported event was unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.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.
 
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Brand Name
LINER NEUTRAL 36 MM I.D.
Common Device Name
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10791112
Report Number0001822565-2020-03744
Device Sequence Number19552058
Product Code LPH
UDI-Device Identifier00889024519923
UDI-Public(01)00889024519923
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K190660
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/11/2021
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
Operator of Device Health Professional
Device Expiration Date06/30/2024
Device Model NumberN/A
Device Catalogue Number30103607
Device Lot Number64374728
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/13/2020
Supplement Date Received by Manufacturer03/09/2021
Initial Report FDA Received Date11/05/2020
Supplement Report FDA Received Date03/11/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		N/A
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
SEE H10
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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