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 PINN SECTOR W/GRIPTION 50MM; 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 US PINN SECTOR W/GRIPTION 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 121732050
Device Problem Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994)
Event Date 02/14/2024
Event Type  Injury  
Event Description
Hip revision due to unknown pain.The ceramic insert and the ceramic has been changed due to strange ceramic bearing.The head has a black mark on the side.The soft tissue seems to have some kind of metallosis.Doi: (b)(6) 2015.Doe: (b)(6) 2024.Reason for revision surgery: problem with the ceramic bearing, pain.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable".Device history lot: a manufacturing record evaluation was performed for the finished device 121732050/583885 lot number, and no non-conformances/manufacturing irregularities were identified.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device 121732050/ 583885 lot number, and no non-conformances / manufacturing irregularities were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.¿ device history lot: a manufacturing record evaluation was performed for the finished device 121732050/ 583885 lot number, and no non-conformances / manufacturing irregularities were identified.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6 problem code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PINN SECTOR W/GRIPTION 50MM
Type of Device
PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key18763709
MDR Text Key336034892
Report Number1818910-2024-04088
Device Sequence Number1
Product Code KWA
UDI-Device Identifier10603295010296
UDI-Public10603295010296
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K093646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/22/2024
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? No
Device Operator Health Professional
Device Catalogue Number121732050
Device Lot Number583885
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/14/2024
Initial Date FDA Received02/22/2024
Supplement Dates Manufacturer Received03/27/2024
04/22/2024
05/14/2024
Not provided
Supplement Dates FDA Received04/01/2024
04/23/2024
05/14/2024
05/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/13/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
DELTA CER HEAD 12/14 32MM +5; DELTA CER INSERT 32ID X 50OD
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient SexMale
-
-