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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHELL POROUS WITH CLUSTER HOLES 56 MM O.D.; PROSTHESIS, HIP
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SHELL POROUS WITH CLUSTER HOLES 56 MM O.D.; 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 06/07/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitant medical products: part: unk cup inserter, lot: unk.Part: 00784101750, lot: 63895075.Part: 00630505632, lot: 64567103.Part: 00801803214, lot: 6345308.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01688.
 
Event or Problem Description
It was reported the cup got cross threaded and would not screw onto the inserter.No adverse events have been reported as a result of the malfunction.Attempts have been made and no further information has been provided.
 
Additional Manufacturer Narrative
Upon reassessment of the reported event, the shell was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
 
Event or Problem Description
Upon reassessment of the reported event, the shell was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
 
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Brand Name
SHELL POROUS WITH CLUSTER HOLES 56 MM O.D.
Common Device Name
PROSTHESIS, HIP
MDR Report Key12025361
Report Number0001822565-2021-01687
Device Sequence Number4257310
Product Code LPH
UDI-Device Identifier00889024118157
UDI-Public(01)00889024118157(17)291231(10)64501531
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K934765
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/02/2021
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 Model NumberN/A
Device Catalogue Number00620005622
Device Lot Number64501531
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/07/2021
Supplement Date Received by Manufacturer10/25/2021
Initial Report FDA Received Date06/18/2021
Supplement Report FDA Received Date11/02/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
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
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