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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910  UNKNOWN HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS, INC. 1818910  UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Angina (1710); Myocardial Infarction (1969); Renal Failure (2041); Thrombosis (2100); Tissue Damage (2104); Respiratory Tract Infection (2420); 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. Pertains to 19 patients.
 
Event Description
On 28-jan-2019: ¿cemented or cementless tha in patients over 80 years with fracture neck of femur: a prospective comparative trial¿ was reviewed for mdr reportability. The study followed 62 patients that were divided into two groups. Group 1: c-stem, ogee cup, and 28mm femoral head. Unknown cement was used. One patient had an intra-operative fracture (unknown location stem or cup). One patient sustained a dislocation. One patient underwent a revision for a loose acetabular cup. Eleven patients experienced abductor dysfunction. One patient experienced ectopic ossification. Seven patients experienced non-fatal systemic complications (1 for dvt, pe, renal failure, mi, pulmonary infection and 2 for cardiac ischaemia).
 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8317884
MDR Text Key135447713
Report Number1818910-2019-83650
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Type of Report Initial,Followup
Report Date 01/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2019
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: 02/07/2019 Patient Sequence Number: 1
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