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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +1.5; HIP FEMORAL HEAD
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DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +1.5; HIP FEMORAL HEAD Back to Search Results
Catalog Number 136551000
Device Problems Corroded (1131); Metal Shedding Debris (1804); Naturally Worn (2988); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Joint Swelling (2356); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 09/29/2015
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.Udi: unavailable.This complaint is the subject of litigation or a legal claim and complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Litigation papers allege corrosion and friction wear is believed to have caused amounts of toxic cobalt-chromium metal ions and particles to be released into the patient's tissue surrounding the implants.As a result, the patient has been experiencing severe pain and difficulty in and around her implant.
 
Manufacturer Narrative
No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot codes were not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Manufacturer Narrative
(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Update 3/28/16- pfs and medical records received.Pfs and medical reviewed for mdr reportability.Pfs and medical records reported hip is left side, this has been updated.Pfs reported inflammation, discoloration, fatigue, lump, swelling, pain, muscle damage and difficulty walking.Patient reported she had twisted hip, crawled to do stairs, had metal poisoning, malaise, stiffness, persistent swelling and hip felt full.Medical records reported limited range of motion, inflammation, popping, grinding, left hip mass.Mri reported pseudotumor, ultrasound reported 2 lesions/alval, and radiographs reportedly showed subtle leg length discrepancy.Lab result report for metal ions was greater than 7 parts per billion.Revision surgical report noted 600ml blood loss, significant amount of fluid with significant amount of metallosis and alval.There was no report of corrosion.Part/lot updated.The complaint was updated on: apr 19, 2016.
 
Manufacturer Narrative
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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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).
 
Event Description
Ppf alleges metal wear.
 
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.H10 additional narrative: 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
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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative:  added: a6 and d9 corrected: d6b and h6 (patient).Replaced surgical intervention with device revision or replacement.
 
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Brand Name
ARTICULEZE M HEAD 36MM +1.5
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key5380323
MDR Text Key36413353
Report Number1818910-2016-11310
Device Sequence Number1
Product Code KXA
Combination Product (y/n)N
PMA/PMN Number
PK980513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number136551000
Device Lot Number2135028
Was Device Available for Evaluation? No
Date Manufacturer Received07/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
APEX HOLE ELIM POSITIVE STOP; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM; SUMMIT POR TAPER SZ5 STD OFF
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient Weight113
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