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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL Back to Search Results
Catalog Number UNK KNEE FEMORAL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Myocardial Infarction (1969); Impaired Healing (2378); No Code Available (3191)
Event Date 01/01/2015
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
An article/literature was received entitled "metaphyseal sleeves for revision total knee arthroplasty: good short-term outcomes¿ literature article "metaphyseal sleeves for revision total knee arthroplasty: good short-term outcomes" by kate e. Bugler et al. Published by the journal of arthroplasty was reviewed. The article purpose: to assess the short term outcomes of the use of metaphyseal sleeves in revision tka. The article reports: this was a study based on a prospective database was compiled of 109 patients undergoing revision tka using a metaphyseal sleeve from depuy. Of the 45 patients remaining after exclusion criteria was applied, full follow up of at least two years was obtained in 35 revision knee arthroplasties. Good patient reported outcomes were found in all measures used. Knee society scores were good or excellent in 83% of patients. There was one intraoperative complications: tibial fracture. There were two early post operative complications: myocardial infarction and wound dehiscence. There were two late post operative complications: joint instability and a femoral fracture. Cement usage was not mentioned. Patella resurfacing was also not conducted in these patients. Stems were also used in most cases and will thus be coded for. Depuy products involved: pfc sigma. Complications: myocardial infarction (1), intra-op tibial fracture (1), wound dehiscence (1), joint instability (1), post-op femoral fracture (1), wound healing delayed (1), surgical intervention (4).
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> no device was received. Root cause undetermined. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameUNKNOWN KNEE FEMORAL
Type of DeviceKNEE FEMORAL
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
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9559574
MDR Text Key185358721
Report Number1818910-2020-00940
Device Sequence Number1
Product Code KWA
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 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK KNEE FEMORAL
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 Received02/12/2020
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: 01/07/2020 Patient Sequence Number: 1
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