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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL SLEEVE; KNEE FEMORAL ACCESSORY
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DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL SLEEVE; KNEE FEMORAL ACCESSORY Back to Search Results
Catalog Number UNK KNEE FEMORAL SLEEVE
Device Problem 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) 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 fem slv ful por 40mm 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 provided photographic evidence, the universal femoral sleeve can be observed during the revision surgery, 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.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 not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the universal fem slv ful por 40mm would contribute to the complained device issue.Based on the investigation findings, 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: 129453236, lot: m0695u, and no non-conformances /manufacturing irregularities were identified.H10 additional narrative: added: b5, d10, h6 (medical device problem code) corrected.
 
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).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.
 
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Brand Name
UNKNOWN KNEE FEMORAL SLEEVE
Type of Device
KNEE FEMORAL ACCESSORY
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 Key18543923
MDR Text Key333255857
Report Number1818910-2024-01431
Device Sequence Number1
Product Code LPH
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
Date FDA Received01/19/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK KNEE FEMORAL SLEEVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/10/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2022
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;
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