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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI TIB TRAY SZ1 LMRL; EARLY INTERVENTION : KNEE TIBIAL TRAY
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DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI TIB TRAY SZ1 LMRL; EARLY INTERVENTION : KNEE TIBIAL TRAY Back to Search Results
Catalog Number 102451100
Device Problems Loss of or Failure to Bond (1068); Loose or Intermittent Connection (1371); Loss of Osseointegration (2408)
Patient Problems Pain (1994); Swelling (2091); Injury (2348); Ambulation Difficulties (2544); Not Applicable (3189); No Information (3190); No Code Available (3191)
Event Date 02/10/2016
Event Type  Injury  
Manufacturer Narrative
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.Depuy synthes has been informed that the catalog number and lot number is not available.
 
Event Description
Patient correspondence: patient reports being revised due to loose screws.Left knee.Patient stated she had pain and couldn't do normal daily activities, such as walking, bending, or squatting before being revised on (b)(6) 2016.Patient also confirmed that the implant was loose (not the screws, as previously stated on the voicemail).Patient was revised with dr.(b)(64) at (b)(6) hospital, (b)(6).
 
Manufacturer Narrative
No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The investigation could not draw any conclusions regarding the reported event.Based on the inability to determine a root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Manufacturer Narrative
Depuy still considers this investigation closed at this time.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Update rec'd 06/20/2016 - the patient's medical records were received.According to the medical records, upon revision the patient's tibial component was loose.At this time the complaint is being updated to reflect a loose tibial component.
 
Manufacturer Narrative
No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The investigation could not draw any conclusions regarding the reported event.Based on the inability to determine a root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Manufacturer Narrative
(b)(4).Concomitant med products: competitor cement: tib:102451100, lot:289832, fem:102407100 lot:239366 insert:102453107 lot:102453107.
 
Manufacturer Narrative
Product complaint #: (b)(4).Concomitant medical products: competitor cement.Tib: 102451100, lot: 289832.Fem: 102407100, lot: 239366.Insert: 102453107, lot: 102453107.(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
In addition to what were previously alleged, litigation alleges injury, physical and mental pain, tibial loosening at the cement to implant interface, mental anguish, diminished quality of life.Doi: (b)(6) 2014; dor: (b)(6) 2016; left knee.
 
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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination 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.
 
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Brand Name
SIGMA HP UNI TIB TRAY SZ1 LMRL
Type of Device
EARLY INTERVENTION : KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
MDR Report Key5503808
MDR Text Key40418027
Report Number1818910-2016-15427
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
PMA/PMN Number
K070267
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 03/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2022
Device Catalogue Number102451100
Device Lot Number289832
Was Device Available for Evaluation? No
Date Manufacturer Received01/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age55 YR
Patient Weight88
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