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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +5; HIP FEMORAL HEAD
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DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +5; HIP FEMORAL HEAD Back to Search Results
Catalog Number 136536320
Device Problem Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); No Code Available (3191)
Event Date 04/07/2016
Event Type  Injury  
Manufacturer Narrative
This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(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
Lawyer is claiming for compensation because of fracture of ceramic hip head right side.Doi (b)(6) 2015, dor (b)(6) 2016.Update 4-may-2017: medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain, fractured liner (not femoral head), grating sensation, metallosis, and wear on the socket edge of the liner.All fragments were removed from the patient.Part/lot was provided and updated and liner was added to the complaint.The liner, cup, and head are being reported.This complaint was updated on: 30-may-2017.
 
Manufacturer Narrative
Lawyer is claiming for compensation because of fracture of ceramic hip head right side.Doi (b)(6) 2015, dor (b)(6) 2016.Update 4-may-2017: medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain, fractured liner (not femoral head), grating sensation, metallosis, and wear on the socket edge of the liner.All fragments were removed from the patient.Part/lot was provided and updated and liner was added to the complaint.The liner, cup, and head are being reported.This complaint was updated on: 30-may-2017.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.If information is obtained that was not available for the initial 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.Product complaint #: (b)(4).Investigation summary: notification was received 08-march-19 advising: "update ad 08 mar 2019.(b)(4) is a reopen of (b)(4) due to receipt of an email notification from kennedys.There are no new allegations.The claim is now actively litigated." review of the notification identified that there was no new information and no new allegations.No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.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.
 
Event Description
New ecm record created in order to update legacy complaint under (b)(4).Lawyer is claiming for compensation because of fracture of ceramic hip head right side.Doi: (b)(6) 2015, dor: (b)(6) 2016.Update 4-may-2017: medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain, fractured liner (not femoral head), grating sensation, metallosis, and wear on the socket edge of the liner.All fragements were removed from the patient.Part/lot was provided and updated and liner was added to the complaint.The liner, cup, and head are being reported.This complaint was updated on: 30-may-2017.Update ad 08 mar 2019.(b)(4) is a reopen of (b)(4) due to receipt of an email notification from kennedys.There are no new allegations.The claim is now actively litigated.Doi: (b)(4) 2015 - dor: (b)(4) 2016 (right hip).This complaint was updated on 08 mar 2019.
 
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.H10 additional narrative:  added: a2 (age), h6, d11.Corrected: g1, g2.Patient code: no code available (3191) is used to capture device revision or replacement.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: notification was received 08-march-2019 advising: "update ad 08 mar 2019.(b)(4) is a reopen of (b)(4) due to receipt of an email notification from (b)(6).There are no new allegations.The claim is now actively litigated." review of the notification identified that there was no new information and no new allegations.No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product / lot combination(s) since release for distribution.Corrective action was not indicated.H6 component code: part/component/sub-assembly term not applicable (g07001) is used to capture product not returned.Corrected: h6 (investigation conclusions).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: notification was received (b)(6) 19, advising: "update ad (b)(6) 2019.(b)(4), is a reopen of (b)(6), due to receipt of an email notification from kennedys.There are no new allegations.The claim is now actively litigated." review of the notification identified that there was no new information and no new allegations.No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.H10 additional narrative: h6 component code: part/component/sub-assembly term not applicable (g07001) is used to capture product not returned.H6 investigation conclusions code: appropriate term/code not available (d17) used to capture undetermined as product was not returned.
 
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Brand Name
DELTA CER HEAD 12/14 36MM +5
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key6598412
MDR Text Key76198098
Report Number1818910-2017-18791
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
K031803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2020
Device Catalogue Number136536320
Device Lot Number8186494
Was Device Available for Evaluation? No
Date Manufacturer Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CORAIL2 NON COL HO SIZE 13.; DELTA CER HEAD 12/14 36MM +5.; DELTA CER INSERT 36ID X 56OD.; PINNACLE 100 ACET CUP 56MM.
Patient Outcome(s) Required Intervention;
Patient Age56 YR
Patient Weight95
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