PINNACLE SECTOR II CUP 54MM 1217-22-054 121722054

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-06 for PINNACLE SECTOR II CUP 54MM 1217-22-054 121722054 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[183264924] Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[183264925] It was reported the patient was with right femoral head ischemic necrosis and had a right total hip arthroplasty and hip arthrolysis on (b)(6) 2018. On (b)(6) 2019, the patient noted the wound exuded fluid. The patient was in hospital on (b)(6) 2019 and had an anti-infective treatment with broad-spectrum antibiotics and regular disinfection. Doi: (b)(6) 2018. The patient was implanted with pinnacle cup to treat ischemic necrosis of the right femoral head. Date of incident: (b)(6) 2019. The patient was re-admitted to the hospital and reported oozing wound exudate. The surgeon diagnosed poor wound healing and a postoperative wound infection. The patient was treated with parenteral and oral antibiotics, as well as daily manual wound disinfection and dressing changes. The wound was fully healed on (b)(6) 2020 with no indication of infection. No revision was performed, and no product defects were reported. Doi: (b)(6) 2019, date of incident: (b)(6) 2019, right hip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-07138
MDR Report Key9801763
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-06
Date of Report2019-03-07
Date of Event2019-02-04
Date Mfgr Received2020-03-17
Device Manufacturer Date2018-04-10
Date Added to Maude2020-03-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. KARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePINNACLE SECTOR II CUP 54MM
Generic NamePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Product CodeMRA
Date Received2020-03-06
Model Number1217-22-054
Catalog Number121722054
Lot Number8770073
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.