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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P FMP HIP; REVISION HEMISPHERICAL SHELL, MULTI-HOLE, P2 COATED, 64MM
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ENCORE MEDICAL L.P FMP HIP; REVISION HEMISPHERICAL SHELL, MULTI-HOLE, P2 COATED, 64MM Back to Search Results
Model Number 430-93-064
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 10/15/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
Event or Problem Description
Revision surgery - due to instability.
 
Additional Manufacturer Narrative
The reason for this revision surgery was reported as instability.The previous surgery and the surgery detailed in this event occurred 3.3 months apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to instability.There were no findings during this evaluation that indicate the reported devices were defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
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Brand Name
FMP HIP
Common Device Name
REVISION HEMISPHERICAL SHELL, MULTI-HOLE, P2 COATED, 64MM
Manufacturer (Section D)
ENCORE MEDICAL L.P
9800 metric blvd
austin,tx 78758-5445
MDR Report Key10836335
Report Number1644408-2020-01036
Device Sequence Number14180148
Product Code LPH
UDI-Device Identifier00888912083225
UDI-Public(01)00888912083225
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K974093
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 company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 02/24/2021
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 Date12/21/2024
Device Model Number430-93-064
Device Catalogue Number430-93-064
Device Lot Number048H1017
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/14/2020
Supplement Date Received by Manufacturer01/27/2021
Initial Report FDA Received Date11/13/2020
Supplement Report FDA Received Date02/25/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
010-55-020 LOT 005A1279; 010-55-020 LOT 005A1309; 010-55-025 LOT 006A1425; 010-55-030 LOT 007A1353; 411-00-350 LOT 931B1979; 495-01-075 LOT 547U1055; 497-44-000 LOT 642C1048; 935-44-264 LOT 828F1017; 010-55-020 LOT 005A1279; 010-55-020 LOT 005A1309; 010-55-025 LOT 006A1425; 010-55-030 LOT 007A1353; 411-00-350 LOT 931B1979; 495-01-075 LOT 547U1055; 497-44-000 LOT 642C1048; 935-44-264 LOT 828F1017
Outcome Attributed to Adverse Event Required Intervention;
Patient Age78 YR
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