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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 22 45
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DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 22 45 Back to Search Results
Model Number BI-MENTUM PE Liner 22,2 / 45
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problem Joint Dislocation (2374)
Event Date 06/03/2022
Event Type  Injury  
Event Description
It was reported that the patient converted from pinnacle dm to constrained liner, chronic dislocater.Explanted dm liner, pe liner and head.There is no reported loosening.There is no reported surgical delay.Doi: (b)(6) 2022.Dor: (b)(6) 2022.Affected side: left.
 
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Brand Name
BI MENTUM PFRK PE LINER 22 45
Type of Device
BI MENTUM PFRK PE LINER 22 45
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key14717815
MDR Text Key294424487
Report Number1818910-2022-50033
Device Sequence Number1
Product Code KWY
UDI-Device Identifier03662200015511
UDI-Public03662200015511
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberBI-MENTUM PE Liner 22,2 / 45
Device Catalogue NumberDS10014522
Device Lot Number2009428A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/16/2022
Distributor Facility Aware Date06/03/2022
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer06/16/2022
Date Manufacturer Received06/03/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARTICUL/EZE BALL 22.225+4 NK; PINNACLE DM LINER 52_45
Patient Outcome(s) Required Intervention;
Patient SexFemale
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