• 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. 1818910 PINNACLE SECTOR II CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

  • 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. 1818910 PINNACLE SECTOR II CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 121722052
Device Problem No Apparent Adverse Event (3189)
Patient Problems Pulmonary Embolism (1498); Thrombosis (2100)
Event Date 03/13/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Clinical adverse event received for deep vein thrombosis in opposite side of surgery and pulmonary embolism. Event is serious and is considered moderate. Event is definitely not related to device and possibly related to procedure. (left hip).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePINNACLE SECTOR II CUP 52MM
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-XXXX
6107428552
MDR Report Key8523841
MDR Text Key142247571
Report Number1818910-2019-90909
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK000306
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,STUDY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121722052
Device LOT NumberJ2103J
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/15/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/17/2019 Patient Sequence Number: 1
-
-