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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SUMMIT POR TAPER SZ6 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDIC INC, 1818910 SUMMIT POR TAPER SZ6 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1570-01-120
Device Problems Corroded (1131); Degraded (1153); Material Discolored (1170); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Injury (2348); Not Applicable (3189); No Code Available (3191)
Event Date 04/21/2017
Event Type  Injury  
Manufacturer Narrative
(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
Complaint description: new etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ litigation papers allege the patient suffers from pain, mental anguish and elevated metal ion levels.Update rec¿d 5/1/2015 - plaintiff¿s preliminary disclosure form was received, which identified part/lot information from patient sticker sheet the complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.The complaint was updated on: 05/19/2015.Update mar 2, 2018: medical records received.After review of medical records for mdr reportability it was reported that the patient was revised to address wear, persistent pain and increasing heavy metal levels.Revision note stated, there was noted to be some corrosion at the trunnion.There were no laboratory values provided the blood metal levels.Added the stem and sleeve product.
 
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
After review of medical records the patient was revised to address pain, heavy metal levels and has previous heart disease.A prosthetic wear in the right hip.Operative notes reported brownish fluid taken and was cultured.There was a corrosion at the trunnion and was removed.Doi: (b)(6) 2006; dor: (b)(6) 2017; right 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.
 
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).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.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: 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
SUMMIT POR TAPER SZ6 STD OFF
Type of Device
SUMMIT HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7380831
MDR Text Key103784268
Report Number1818910-2018-56334
Device Sequence Number1
Product Code LPH
UDI-Device Identifier10603295059370
UDI-Public10603295059370
Combination Product (y/n)N
PMA/PMN Number
K001991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/02/2018
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 Model Number1570-01-120
Device Catalogue Number157001120
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/02/2018
Initial Date FDA Received03/29/2018
Supplement Dates Manufacturer Received08/22/2018
10/02/2018
03/26/2019
04/29/2020
04/29/2020
Supplement Dates FDA Received09/17/2018
10/23/2018
04/05/2019
05/06/2020
05/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient Weight123
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