Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 22 41
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 22 41 Back to Search Results
Model Number BI-MENTUM PE Liner 22,2 / 41
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 03/03/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
 
Event or Problem Description
It was reported that the doctor said the patient dislocated their hip multiple times due to inadequate abductors.Pinnacle dm liner was removed and replaced with a constrained liner.Zimmer biomet stem was retained so their 28mm head was used.Doi: (b)(6) 2021.Dor: (b)(6) 2021; (left hip).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BI MENTUM PFRK PE LINER 22 41
Common Device Name
BI MENTUM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11561155
Report Number1818910-2021-50003
Device Sequence Number4183126
Product Code LZO
UDI-Device Identifier03662200015498
UDI-Public03662200015498
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/03/2021
Report Date (Section F) 03/24/2021
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? Yes
Operator of Device Health Professional
Device Model NumberBI-MENTUM PE Liner 22,2 / 41
Device Catalogue NumberDS10014122
Device Lot Number2002646A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date03/03/2021
Device Age8 MO
Event Location Hospital
Date Report to Manufacturer03/24/2021
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/24/2021
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
BI MENTUM PFRK PE LINER 22 41; PINNACLE DM LINER 48_41; UNKNOWN HIP ACETABULAR CUP
Outcome Attributed to Adverse Event Required Intervention;
Date Report Sent to FDA03/24/2021
-
-