PINNACLE MTL INS NEUT36IDX54OD 121887354

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-02-16 for PINNACLE MTL INS NEUT36IDX54OD 121887354 manufactured by Depuy Orthopaedics, Inc. 1818910.

Event Text Entries

[100247244] (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


[100247245] Der states that the patient had a depuy ceramic on metal tha approximately 10 years ago patient was painful. Surgeon removed the pinnacle ultimate liner and corail stem with a ceramic head. Surgeon replaced pinnacle poly liner into retained pinnacle cup size 54. Surgeon place a new corail revision stem with a new ceramic head. It was also reported that there was non-cemented loosening interface. Doi: approximately 10 years ago. Dor: (b)(6) 2018; left hip.
Patient Sequence No: 1, Text Type: D, B5


[104468214] (b)(4). No device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. 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


MAUDE Entry Details

Report Number1818910-2018-53511
MDR Report Key7276290
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-02-16
Date of Report2018-01-23
Date of Event2018-01-23
Date Mfgr Received2018-03-09
Device Manufacturer Date2008-06-05
Date Added to Maude2018-02-16
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 ContactMR. CHAD GIBSON
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465820988
Manufacturer CountryUS
Manufacturer Postal465820988
Manufacturer Phone5743725905
Manufacturer G1DEPUY INTERNATIONAL LTD. 8010379
Manufacturer StreetST. ANTHONY'S RD
Manufacturer CityLEEDS LS118 DT
Manufacturer CountryUK
Manufacturer Postal CodeLS11 8 DT
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePINNACLE MTL INS NEUT36IDX54OD
Generic NameHIP METAL ACETABULAR LINERS
Product CodeOVO
Date Received2018-02-16
Catalog Number121887354
Lot Number2641413
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-02-16

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