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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Patient Problems Pulmonary Embolism (1498); Bone Fracture(s) (1870); Unspecified Infection (1930); Injury (2348); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)
Event Date 03/01/2014
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). (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, "the s-rom hydroxyapatite proximally coated modular femoral stem in revision hip replacement " written by a. M. Imbuldeniya, w. K. Walter, b. A. Zicat, and w. L. Walter published by the bone and joint journal doi:10. 1302/0301-620x. 96b6. 33381 accepted by publisher 4 march 2014 was reviewed. The article's purpose: "to present long-term clinical and radiological results of the ha version of (the s-rom stem) in revision thr. Data was compiled from 397 revisions between april 1992 and december 2002 with mean age of patients of 69 years old. Original implants are not identified in the article. Depuy products utilized: srom stem and sleeve (augment). Adverse event: death (one patient died within 2 days of surgery who experienced a myocardial infarction), radiologic findings without associated interventions (cortical hypertrophy, stress shielding, endosteal spot welds, bony pedestal), heterotopic ossification which led to sciatic nerve palsy and required excision and neurolysis (refer to page 733 paragraph 1), infection (interventions included two-stage surgery, antibiotics-targeted and long term), post operative fracture (interventions included fixation), intra operative fracture (interventions included cerclage wiring), loose femoral component (intervention included revision), and pe.
 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP 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 drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9316502
MDR Text Key184988152
Report Number1818910-2019-113531
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP 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 Received01/10/2020
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: 11/13/2019 Patient Sequence Number: 1
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