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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 4 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 4 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 101204040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
Event Date 11/05/2012
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.Initial reporter occupation: non-healthcare professional ¿ attorney.(b)(4).
 
Event Description
Litigation alleges that the acetabular cup eventually detached, disconnected, created metallic debris, and/or loosened from patient's acetabulum, caused severe pain, and inhibited patient's ability to walk.Ppf alleges, metal wear, metallosis, and elevated metal ions.Doi: (b)(6) 2009; dor: (b)(6) 2012 (left hip).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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.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 will be filed as appropriate.
 
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Brand Name
TRI-LOCK BPS SZ 4 STD OFFSET
Type of Device
TRILOCK HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8189798
MDR Text Key131164047
Report Number1818910-2018-79001
Device Sequence Number1
Product Code KWA
UDI-Device Identifier10603295000754
UDI-Public10603295000754
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
Report Date 11/30/2018
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 Catalogue Number101204040
Device Lot NumberC5NEV1000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/30/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received09/26/2019
Supplement Dates FDA Received10/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
Patient Weight59
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