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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA CERAMIC TAPER LINER, SIZE II / 36 I.D; PROSTHESIS, HIP

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ZIMMER GMBH BIOLOX® DELTA CERAMIC TAPER LINER, SIZE II / 36 I.D; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4) g2.Report source: india.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported in a primary hip replacement case the liner was unable to fix in the cup adequately, was identified there might be some defect in the liner immediately surgeon used another ceramic liner and completed the surgery.No consequences or impact to the patient.Diligence is completed and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h3, h6, h11.The insert was returned for investigation.The rim and the articulation surface are inconspicuous.On the backside, it is possible to see a series of scratches and metal transfer.Commonly observed metal transfers from the seating are also visible all around the taper region.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Review of the manufacturing records confirm that the insert was manufactured according to specification; therefore, it is not expected that the manufacturing process contributed to the reported issue.As the shell involved in the reported event was not returned, a product evaluation on this item could not be performed and an assembly test could not be carried out.Based on the available information, a definitive root cause for the reported event could not be established.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
BIOLOX® DELTA CERAMIC TAPER LINER, SIZE II / 36 I.D
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ   8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key18825685
MDR Text Key336768417
Report Number0009613350-2024-00077
Device Sequence Number1
Product Code KWA
UDI-Device Identifier00889024429901
UDI-Public(01)00889024429901(17)330614(10)3162379
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/16/2024
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
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue Number00877501036
Device Lot Number3162379
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/06/2023
Initial Date FDA Received03/04/2024
Supplement Dates Manufacturer Received05/14/2024
Supplement Dates FDA Received05/16/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2023
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 Age40 YR
Patient SexMale
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