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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL STEM Back to Search Results
Catalog Number UNK KNEE FEMORAL STEM
Device Problems Loss of or Failure to Bond (1068); Inadequacy of Device Shape and/or Size (1583)
Patient Problems Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).

 
Event Description

The literature article entitled ¿metaphyseal sleeves in revision total knee arthroplasty: minimum seven-year follow-up study¿, written by sanjeev agarwal, et al. Published in the knee 25 (2018) 1299-1307, https://doi. Org/10. 1016/j. Knee. 2018. 09. 010, was reviewed. The purpose of the article was to report early results with the use of metal, porous coated metaphyseal sleeves in revision knee replacements. The authors present seven years of follow-up of the initial cohort. This is, as of yet, the longest follow-up report in literature. Products used: pfc & tc3, depuy. Index revision indications: aseptic loosening, infection, stiffness (four of these patients were revised to a noiles, depuy and underwent manipulations under anesthesia with continued restricted flexion); one patient was in her mid-40¿s during index revision and had two further re-revisions for stiffness (these will be combined together due to insufficient information regarding the revisions), developed late infection four years after third revision and recently, in her mid-50¿s opted for a two-stage arthrodesis-it is reasonable to conclude that this late infection four years after the last revision was not related to the implant, pain, instability. Re-revision indications: aseptic loosening (one patient revised for loosening had disengagement at the stem sleeve junction secondary to a technical error of tight fit of stem in femoral diaphysis), infection (two-stage procedure, transfemoral amputation, distal femoral replacement prosthesis used for reconstruction, antibiotic suppression therapy), persistent pain, instability. Other notes: the discussion section mentions multiple further procedures including amputation. The article does not discuss patellar resurfacing or cement manufacturer.

 
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Brand NameUNKNOWN KNEE FEMORAL STEM
Type of DeviceKNEE FEMORAL STEM
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 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr
warsaw, IN 46581-0988
6107428552
MDR Report Key9739261
MDR Text Key189844729
Report Number1818910-2020-05641
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK KNEE FEMORAL STEM
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2020
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

Patient TREATMENT DATA
Date Received: 02/21/2020 Patient Sequence Number: 1
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