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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE CRS FB TIB BASE SZ 5 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY

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DEPUY IRELAND - 9616671 ATUNE CRS FB TIB BASE SZ 5 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY Back to Search Results
Model Number 1506-40-005
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Insufficient Information (4580)
Event Date 11/14/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
The patient was revised due to loosening of the tibial component at the cement to implant interface.Depuy cement was used.Doi: unknown.Dor: (b)(6) 2022.Affected side: left knee.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Additional information received indicated that the patient was revised due to loosening of the tibial component at the cement to implant interface.Depuy cement was used.It was also reported that from the image of the implant, it was visible that the threads on the tibial stem sheared off due to micromotion after loosening in the cement mantle.Additional information: a.The patient was revised without incident.B.I am unaware of the initial surgery date.C.The cement used was stryker simplex.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was not returned to depuy synthes for evaluation.The photo and x-ray investigation found nothing indicative of a device nonconformance, for loosening to be confirmed a series of chronological x-rays is needed.The reported allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the investigation was not able to retrieve the required lot code.Corrected: d10 concomitant.
 
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Brand Name
ATUNE CRS FB TIB BASE SZ 5 CEM
Type of Device
ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork IN
EI 
Manufacturer (Section G)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork IN
EI  
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key16023238
MDR Text Key305896723
Report Number1818910-2022-25916
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/21/2022
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? Yes
Device Operator Health Professional
Device Model Number1506-40-005
Device Catalogue Number150640005
Device Lot Number8503426
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/14/2022
Initial Date FDA Received12/21/2022
Supplement Dates Manufacturer Received12/16/2022
12/29/2022
Supplement Dates FDA Received12/26/2022
01/02/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
COMPETITOR BONE CEMENT; UNKNOWN BONE CEMENT; UNKNOWN BONE CEMENT; UNKNOWN KNEE TIBIAL INSERT; UNKNOWN KNEE TIBIAL INSERT; UNKNOWN KNEE TIBIAL STEM; UNKNOWN KNEE TIBIAL STEM; UNKNOWN KNEE TIBIAL TRAY
Patient Outcome(s) Required Intervention;
Patient SexMale
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