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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 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 7 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1012-04-070
Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tissue Damage (2104); Test Result (2695); No Code Available (3191)
Event Date 11/08/2011
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional: "attorney".(b)(4).
 
Event Description
Litigation alleges that due to metallosis and failure of osseointegration of the pinnacle device, patient underwent revision on both sides.Update: in addition to what were previously alleged, ppf alleges component fracture, metal wear, metallosis, and elevated metal ions.Doi: (b)(6) 2009; dor: (b)(6) 2011; (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.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
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.
 
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Brand Name
TRI-LOCK BPS SZ 7 STD OFFSET
Type of Device
TRILOCK HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
MDR Report Key8590767
MDR Text Key144410011
Report Number1818910-2019-92802
Device Sequence Number1
Product Code KWA
UDI-Device Identifier10603295000785
UDI-Public10603295000785
Combination Product (y/n)N
PMA/PMN Number
K073570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 04/16/2019
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 Number1012-04-070
Device Catalogue Number101204070
Device Lot NumberCR9DN1000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/16/2019
Initial Date FDA Received05/08/2019
Supplement Dates Manufacturer Received04/13/2020
05/03/2020
Supplement Dates FDA Received04/22/2020
05/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age40 YR
Patient Weight94
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