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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 1365-52-000
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Code Available (3191)
Event Date 10/16/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint#: (b)(4).(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
When surgeon was about to implant femoral head, he noticed some scratches on the head.He refused it and asked for a new one.No patient harm,2 minute delay, time to open new head.Pls replace.(b)(6).Was surgery delayed due to the reported event? yes.If yes, number of minutes: 2 minutes.Action taken when event occurred? opened new head.Was procedure successfully completed? yes.Were fragments generated? no.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences? no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study? unknown.(b)(4).Device property of: none.Device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.: true.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned femoral head finds minor cosmetic damage.It was not possible to conclude any processing or packaging anomaly was a contributing factor.It has suspected the damage occurred after distribution for end use.It is not possible to determine how or at what point the damage occurred.A review of the device manufacturing records found no deviations or anomalies.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: a review of the device manufacturing records found no deviations or anomalies.Device history review: a review of the device manufacturing records found no deviations or anomalies.
 
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Brand Name
ARTICULEZE M HEAD 36MM +5
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 Key10763411
MDR Text Key213923517
Report Number1818910-2020-23672
Device Sequence Number1
Product Code JDI
UDI-Device Identifier10603295033936
UDI-Public10603295033936
Combination Product (y/n)N
PMA/PMN Number
K980513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1365-52-000
Device Catalogue Number136552000
Device Lot Number9531264
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2020
Initial Date Manufacturer Received 10/16/2020
Initial Date FDA Received10/30/2020
Supplement Dates Manufacturer Received10/26/2020
11/15/2020
01/29/2021
Supplement Dates FDA Received11/05/2020
12/05/2020
01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARTICULEZE M HEAD 36MM +5; ARTICULEZE M HEAD 36MM +5
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