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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problems Nonstandard Device (1420); Naturally Worn (2988)
Patient Problems Fatigue (1849); Hypovolemic Shock (1917); Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Weakness (2145); Anxiety (2328); Injury (2348); Depression (2361); Test Result (2695); No Code Available (3191)
Event Date 07/13/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation summary: no device associated with this report was received for examination. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. Initial reporter occupation: lawyer. (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
Asr claim letter received. Claim letter alleges psycho-physical injuries, elevated metal ions, calcification in the great trochanter, toxic debris in the body, inflammation caused by metallosis due to wear, development of renal neoplasia, bone injury, muscle and nerve injuries, anxious depressive syndrome, pain, slight lameness, weakness, muscular hypotrophy, length of limbs difference, stiffness, swelling, fatigue, and anxiety. It was also alleged that the patient was transported to icu post op for hypovolemic shock. Lab result shows metal ion levels above 7ppb. Left hip.
 
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Brand NameUNKNOWN HIP ACETABULAR CUP
Type of DeviceHIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key8571143
MDR Text Key143793447
Report Number1818910-2019-92218
Device Sequence Number0
Product Code KWY
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 04/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR CUP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Type of Device Usage Initial
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 05/01/2019 Patient Sequence Number: 1
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