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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); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Unspecified Infection (1930); Pain (1994); Swelling (2091); Thyroid Problems (2102); Blurred Vision (2137); Anxiety (2328); Hypoesthesia (2352); Test Result (2695); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.   the correction/removal reporting number listed applies to the corresponding product code sold domestically. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. 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.
 
Event Description
Claim letter received alleging elevated blood heavy metal levels, formation of peri and intra-articular serous gatherings, pain, respiratory disorders, hyperthyroidism, enlargement of the thyroid gland, irregular blood pressure, irritability, insomnia, recurring headaches, palpitations, numbness in the fingers and toes, blurred vision, continuous lacrimation, increased anxiety, lowered mood, walking difficulty, swelling, sensations of instability, metal poisoning and infection. Doi: (b)(6) 2015; dor: not indicated; (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 anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key8592790
MDR Text Key144478674
Report Number1818910-2019-92924
Device Sequence Number0
Product Code KWY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Recall
Type of Report Initial
Report Date 04/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR CUP
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2019
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
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 05/08/2019 Patient Sequence Number: 1
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