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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 44MM M SPEC-2; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 44MM M SPEC-2; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 136560000
Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Event Date 11/19/2015
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
 
Event Description
Pfs alleges clicking and shooting pain, swelling, sleeping difficulty, limited mobility, walking difficulty, metallosis.After review of medical records, it was stated that the patient was revised due to leg length inequality - 12 mm shorter in the left side compared to the right.Revision notes reported that cup was well fixed and did not have a great deal of anteversion but combined anteversion was 35 degrees and no evidence of instability.It was also indicated that patient had elevated metal ion levels but no lab results were provided.Doi: (b)(6) 2009 - dor: (b)(6) 2015, (left hip).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).Added: b5, h6.Corrected: a1.
 
Event Description
Ppf alleges pseudotumor and metal wear.
 
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Brand Name
12/14 ARTICUL 44MM M SPEC-2
Type of Device
ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8447911
MDR Text Key139693898
Report Number1818910-2019-88309
Device Sequence Number1
Product Code JDI
UDI-Device Identifier10603295034018
UDI-Public10603295034018
Combination Product (y/n)N
PMA/PMN Number
K060031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2013
Device Catalogue Number136560000
Device Lot Number2719694
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/04/2019
Initial Date FDA Received03/25/2019
Supplement Dates Manufacturer Received04/08/2019
09/06/2019
Supplement Dates FDA Received04/12/2019
09/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age64 YR
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