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 UNIVERSAL STEM 115X18MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
  • 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 UNIVERSAL STEM 115X18MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS Back to Search Results
Catalog Number 867432
Device Problems Fracture (1260); Noise, Audible (3273); Migration (4003)
Patient Problems Pain (1994); Physical Asymmetry (4573)
Event Date 01/01/2024
Event Type  Injury  
Manufacturer Narrative
Product complaint (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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.
 
Event Description
The patient stated that he had not fallen.The initial situation was an lps with a sleeve on the femur.The x-ray showed a fracture of the stem to the sleeve, and the x-ray also showed that the prosthesis was sinking in and there was a difference in the length of the leg.The implant on the femur was explanted and a new lps implant was implanted in a single session.
 
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.
 
Event Description
Additional information was received and confirmed that only the stem was fractured and not the sleeve.There were no reports of surgical delay.It was a planned surgical revision due to breakage of the stem.The femur components and the tibia insert were revised and only the tibia stem was not exiled.
 
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 that 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.
 
Event Description
Additional information was received.1.Was this a right knee custom lps construct? yes.2.Were there two segmental components utilized with the distal femoral construct? no.3.Was there any indication, that the femoral sleeve fractured? any additional information that can be provided to confirm, the correct product codes would be appreciated.The patient, heard a crack.And after that, the patient had pain.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the patient stated, that he had not fallen.The initial situation was an lps with a sleeve on the femur.The x-ray showed, a fracture of the stem to the sleeve.And the x-ray also showed, that the prosthesis was sinking in and there was a difference in the length of the leg.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual and photographic inspection of the returned device visual inspection of the returned sample revealed, that the universal stem 115x18mm fluted, has the broken threaded head of the stem stuck inside the assembly hole.This part of the stem is broken in two pieces.Upon observing, the fractured surface, it can be seen that it is a high cycle low stress fatigue kind of fracture, due to polished surface observed.Indicating, that the fracture was caused by material overload over an indeterminate period.Additionally, upon reviewing the photographic evidence provided, the universal femoral sleeve, during the revision surgery can be observed, showing little fixation with the patient's bone.Which may indicate, possible loosening and movement from the original site, due to the weight exerted in that area by the patient.And with this evidence, it is reasonable to concluded, that audible sound would be present at the time the devices completely separated due to the fracture or due to unintended movement of the sleeve and the stem.With the information provided is not possible to determine, a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A dimensional inspection was unable to be performed, due to post manufacturing damage.The overall complaint was confirmed.As the observed, condition of the universal stem 115x18mm fluted would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to component failure.And it has been determined, that no corrective and/or preventative action is proposed.There is no indication, that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed, for the finished device product code: 867432, lot#: j13h70.And no non-conformances /manufacturing irregularities were identified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNIVERSAL STEM 115X18MM FLUTED
Type of Device
UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key18543927
MDR Text Key333255828
Report Number1818910-2024-01430
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295217923
UDI-Public10603295217923
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P830055
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 01/19/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number867432
Device Lot NumberJ13H70
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/11/2024
Initial Date FDA Received01/19/2024
Supplement Dates Manufacturer Received01/17/2024
02/29/2024
02/29/2024
04/10/2024
Supplement Dates FDA Received01/29/2024
03/05/2024
03/12/2024
04/10/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2018
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
CTM LPS 31MM SLEEVE; CTM LPS 31MM SLEEVE; CTM LPS DIST FEMUR XS LP RIGHT; CTM LPS DIST FEMUR XS LP RIGHT; LCS STEM EXT 18X110; LCS STEM EXT 18X110; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 25MM; SROM*NRH REPL HINGE PIN/XSM/SM; UNIVERSAL FEM SLV FUL POR 40MM; UNKNOWN KNEE TIBIAL INSERT
Patient Outcome(s) Required Intervention;
-
-