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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER STANDARD 3.5 MM OFFSET 36 MM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. LINER STANDARD 3.5 MM OFFSET 36 MM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Medical Device Problem Code Difficult to Insert (1316)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/28/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and 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 during total hip procedure the liner would not seat properly in the shell; sat proud 4mm of the rim.Opened a second liner which was seated perfectly on the first try.No additional information.
 
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, g3, h2, h3, h6.Complaint sample was evaluated and the reported event was confirmed.A trilogy poly liner was returned for evaluation.As returned, damage is seen on the backside and rim feature.A witness mark on the polar boss indicates the liner was misaligned during the attempt to install.The device was conforming to specifications during manufacturing.Device history record (dhr) was reviewed and no discrepancies were found.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 or Problem Description
No further event information available at the time of this report.
 
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Brand Name
LINER STANDARD 3.5 MM OFFSET 36 MM
Common Device Name
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key12210392
Report Number0001822565-2021-02037
Device Sequence Number4392533
Product Code LPH
UDI-Device Identifier00889024123762
UDI-Public(01)00889024123762(17)250609(10)64772583
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K002960
Number of Events Summarized1
Summary Report (Y/N)N
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) 10/21/2021
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
Operator of Device Health Professional
Device Expiration Date08/09/2025
Device Model NumberN/A
Device Catalogue Number00630505036
Device Lot Number64772583
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/01/2021
Supplement Date Received by Manufacturer10/18/2021
Initial Report FDA Received Date07/22/2021
Supplement Report FDA Received Date10/21/2021
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
UNKNOWN 50MM SHELL; UNKNOWN 50MM SHELL
Patient Age54 YR
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