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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 7 HI OFFSET; HIP FEMORAL STEM/SLEEVE
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DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 7 HI OFFSET; HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number 101214070
Device Problems Corroded (1131); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Weakness (2145); Joint Dislocation (2374); No Code Available (3191)
Event Date 10/27/2015
Event Type  Injury  
Manufacturer Narrative
This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.If information is obtained that was not available for the initial medwatch, 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 record received.Litigation alleges corrosion and friction wear, toxic cobalt-chromium metal debris, pain and difficulty with the implant.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Pfs alleges physical injuries, pain, altered gait, loss in range of motion, weakness in hips, leg weakness, and muscle loss.Medical record received.After review of mdr reportability, the patient was revised to address instability and dislocation.Revision notes reported there was an area of metallosis, darkish colored tissue.There was no evidence of loosening.
 
Manufacturer Narrative
Product complaint #
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> pc-(b)(4).Investigation summary
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> 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.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.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 #
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> (b)(4).Investigation summary
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> 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.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.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).
 
Event Description
Ppf alleges dislocation, metal wear and metallosis, however dislocation and metallosis were already reported.
 
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Brand Name
TRI-LOCK BPS SZ 7 HI OFFSET
Type of Device
HIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7040595
MDR Text Key92306584
Report Number1818910-2017-29222
Device Sequence Number1
Product Code KXA
Combination Product (y/n)N
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 10/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2021
Device Catalogue Number101214070
Device Lot Number129680
Was Device Available for Evaluation? No
Date Manufacturer Received09/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age54 YR
Patient Weight118
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