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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 47X28 BRN HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

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DEPUY ORTHOPAEDICS INC US SELF CENT HIP 47X28 BRN HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Model Number 1035-47-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Damage to Ligament(s) (1952); Pain (1994); Injury (2348); No Code Available (3191)
Event Date 09/28/2020
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.
 
Event Description
It was reported that this patient had her left hip replaced 20 + years ago, the surgeon, hospital where she had her surgery is unknown. The xrays revealed the patient most likely had a hps ii stem with a bipolar shell. The patient is a regular patient of (b)(6) now and spike with him about her painful left hip. Dr. (b)(6) determined the source of the pain would be due to the loss of cartilage and bone in the acetabulum due to 20+ years of a metal shell articulation on the cartilage and bone. It was decided he would revise the construct to a total hip from a hemi. Dr. (b)(6) removed the femoral head and bipolar shell while leaving the hps ii stem in situ. He reamed the acetabulum and prepared for a pinnacle cup. A cup implant and liner was implanted and a new femoral hip ball was implanted on the stem. The lot #¿s of the femoral stem and bipolar shell were unable to be retrieved. Doi: 20 + years ago, dor: (b)(6) 2020, affected side: left hip.
 
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Brand NameSELF CENT HIP 47X28 BRN
Type of DeviceHEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10677568
MDR Text Key211295750
Report Number1818910-2020-22277
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K812672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number1035-47-000
Device Catalogue Number103547000
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 Received11/09/2020
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: 10/14/2020 Patient Sequence Number: 1
Treatment
(HPS II STEM); ARTICUL/EZE BALL 28 +1.5 GR
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