• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +2 ASR HIP SYSTEM : HIP FEMORAL SLEEVE

  • 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 INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +2 ASR HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 999800312
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/12/2020
Event Type  Injury  
Event Description
Left tha performed in (b)(6) 2008 due to osteoarthritis. Asr implants and depuy summit stem were used. Revision was completed secondary to pain and metalosis. Operative notes stated that there was a slight increase in iron levels. Mri did not show evidence of pseudotumor. Significant inflammation of the capsule and erosion of the bony inferior aspect of the acetabulum was observed. Patient also experienced significant trunnionosis from the cobalt chrome head. Doi: (b)(6) 2008. Dor: (b)(6) 2020. Left hip.
 
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameADAPTER SLEEVES 12/14 +2
Type of DeviceASR HIP SYSTEM : HIP FEMORAL SLEEVE
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13172667
MDR Text Key286923866
Report Number1818910-2022-00246
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number999800312
Device Lot Number2557785
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 01/05/2022 Patient Sequence Number: 1
Treatment
ASR ACETABULAR CUPS 58; ASR UNI FEMORAL IMPL SIZE 51; SUMMIT DUOFIX TAP SZ5 STD OFF
-
-