RSP 509-00-032

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-25 for RSP 509-00-032 manufactured by Encore Medical L.p..

Event Text Entries

[186137767] The reason for this revision surgery was reported as an infection. The previous surgery and the surgery detailed in this event occurred 11. 9 months apart. Initial or prolonged hospitalization was required. 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 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 an infection. There were no findings during this evaluation that indicate the reported devices were the source or had a direct connection with the patient's infection. 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 infection or inhibited the patient's immune system. There are multiple factors that may contribute to an infection that are outside the control of djo surgical. There are no indications of a product or process issue affecting implant safety or effectiveness.
Patient Sequence No: 1, Text Type: N, H10


[186137768] Revision surgery - patient was infected, all original implants were removed and an antibiotic spacer was put in.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644408-2020-00223
MDR Report Key9878908
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-25
Date of Report2020-03-24
Date of Event2020-02-24
Date Mfgr Received2020-02-24
Device Manufacturer Date2019-01-12
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTEFFANY HUTTO
Manufacturer Street9800 METRIC BLVD
Manufacturer CityAUSTIN, TX 78758-5445,
Manufacturer CountryUS
Manufacturer G1ENCORE MEDICAL L.P.
Manufacturer Street9800 METRIC BLVD
Manufacturer CityAUSTIN, TX 78758-5445,
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRSP
Generic NameRSP STANDARD HUMERAL SOCKET INSERT, 32MM, HXE-PLUS
Product CodePHX
Date Received2020-03-25
Model Number509-00-032
Catalog Number509-00-032
Lot Number377P1432
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerENCORE MEDICAL L.P.
Manufacturer Address9800 METRIC BLVD AUSTIN, TX 78758-5445, US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-25

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