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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 TRI-LOCK BPS SZ 4 HI OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDIC INC, 1818910 TRI-LOCK BPS SZ 4 HI OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 101214040
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Fall (1848); Unspecified Infection (1930); Inflammation (1932); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Weakness (2145); Injury (2348); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 11/02/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Pfs and medical records received. There is no new pfs allegation. After the review of medical records for reportability, patient was revised to address painful right total hip replacement. Revision notes stated that there was minimal evidence of metal on metal disease. Clinic visit reported of continued elevated metal ions, pain, weakness, stiffness and instability leading to difficulty walking or climbing stairs, decrease range of motion and pain is worse with hip flexion. Cobalt and chromium are above 7pbb.
 
Event Description
Plaintiff¿s fact sheet received. In addition to what were previously alleged, pfs alleges bodily injuries including muscle spasms, neuropathy, muscle atrophy, falls, damage to other limbs including knee and back issues, and impaired adl.
 
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
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.
 
Event Description
Litigation received. Litigation alleges pain, swelling, inflammation, infection and damage to surrounding bone and tissue, multiple dislocations and lack of mobility.
 
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Brand NameTRI-LOCK BPS SZ 4 HI OFFSET
Type of DeviceTRILOCK HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6103142063
MDR Report Key7074423
MDR Text Key110394148
Report Number1818910-2017-50558
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/17/2019
Device Catalogue Number101214040
Device Lot NumberD46B21
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/19/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/01/2017 Patient Sequence Number: 1
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