• 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 Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/23/2019
Event Type  Injury  
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.
 
Event Description
It was reported that the patient had a left asr hip performed back on (b)(6) 2009. The orthopedic surgeon that was performing the revision did not tell me much about this patient. From speaking with the pa, he said the patient was not complaining of pain so much, but more from a clunking noise and impingement feeling. From what i understood the patient was not worked up for blood ion levels, etc. If he was, i wasn't aware of the results. Both the surgeon and pa both were talking about this revision from the noise/impingent. Once the surgeon opened the patient up, he did say that he saw some signs of metal/dark tissue. After he knocked off the asr head, he showed me the dark tissue and metallosis he said was around the trilock stem trunion. He said that the surrounding tissue was in good shape. He looked over the asr head and cup for large abrasions that he thought may have been creating that sound/ impingement, however there were no marks anywhere. He removed the cup using the zimmer explant system. He then reamed the acetabulum and implanted a 58 pinnacle multihole cup. He put in 4 screws and a 40x58 +4/10 degree liner. He left the trilock stem in place. We trialed with a 40 +1. 5 head and implanted that head size in a ceramic ts head. He was happy with the stability and leg lengths. Doi: (b)(6) 2009. Dor: (b)(6) 2019. Left hip.
 
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 Key11165018
MDR Text Key226649971
Report Number1818910-2021-00996
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 company representative,consum
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2014
Device Catalogue Number999800312
Device Lot Number2820776
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 01/13/2021 Patient Sequence Number: 1
Treatment
ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 58; ASR UNI FEMORAL IMPL SIZE 51; TRI-LOCK BPS SZ 7 STD OFFSET
-
-