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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 502-03-52D
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 10/07/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned.
 
Event or Problem Description
As reported: "the revision was done due to dislocation.No further information is available from the hospital." spoke to rep: left hip, revision due to dissociation of the liner from the shell.Patient was revised from a trident constrained liner, size d with lfit v40 22 + 3 mm head to an mdm liner and insert with lfit v40 22 + 8mm v40 head.
 
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Brand Name
PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
MDR Report Key12745022
Report Number0002249697-2021-01823
Device Sequence Number14572777
Product Code LPH
UDI-Device Identifier07613327040128
UDI-Public07613327040128
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K081171
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/03/2021
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? No
Operator of Device Health Professional
Device Expiration Date03/31/2023
Device Model Number502-03-52D
Device Catalogue Number502-03-52D
Device Lot NumberTJ899D
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/08/2021
Initial Report FDA Received Date11/03/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured03/05/2018
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
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age65 YR
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