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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR POLY/METAL HEMI

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Catalog Number UNK HIP ACETABULAR
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Calcium Deposits/Calcification (1758); Stroke/CVA (1770); Unspecified Infection (1930); Pain (1994); Pneumonia (2011); Renal Failure (2041); Thrombosis (2100); Urinary Retention (2119); Urinary Tract Infection (2120); Heart Failure (2206); Joint Dislocation (2374)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
A literature article was received entitled: "cementless bipolar hemiarthroplasty using a hydroxyapatite coated long stem for osteoporotic unstable intertrochanteric fractures", published in the journal of arthroplasty vol. 26 no. 4 2011, and was reviewed for mdr reportability by a clinician. The authors of the study sought to compare the benefits of using hydroxyapatite coated long stems in a senile population with unstable intertrochanteric fractures. The authors used depuy uncemented hydroxyapatite-coated kar stems paired with depuy self-centering bi-polar heads. Results of the 87 hip study demonstrated positive results. There were no cases of aseptic loosening or subsidence, nor significant leg length discrepancy. The authors did report a series of post-operative medical complications, and some orthopedic complications, as follows: medical post-op: delirium 18 patients. Urinary retention 16 patients. Urinary tract infection 5 patients. Deep vein thrombosis 3 patients. Pneumonia 1 patient. Congestive heart failure 1 patient. Cerebrovascular accident 1 patient. Sore 1 patient. Acute renal failure 1 patient. Died during hospital stay 0 patients. Orthopedic post-op: dislocation 2 patients. Infection 2 patients. Trochanteric nonunion 1 patient. Heterotopic ossification 3 patients. The study did not provide specific patient information, but rather addressed the population by complications only. There was no specific product or lot code information for the implanted devices provided within the article.
 
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Brand NameUNKNOWN HIP ACETABULAR POLY/METAL HEMI
Type of DeviceHIP ACETABULAR POLY/METAL HEMI
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, PA 19380-0988
6103142063
MDR Report Key8704954
MDR Text Key148201934
Report Number1818910-2019-96125
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeKS
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
Report Date 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR
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 Received08/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/17/2019 Patient Sequence Number: 1
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