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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT

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DEPUY CMW - 9610921 DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT Back to Search Results
Model Number 5450-31-500
Device Problems Loss of or Failure to Bond (1068); Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Fatigue (1849); Weakness (2145); No Code Available (3191); Joint Laxity (4526); Muscle/Tendon Damage (4532)
Event Date 09/11/2019
Event Type  Injury  
Manufacturer Narrative
(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
Clinical adverse event received for ruptured patellar tendon: tendon rupture.Event is serious and is considered severe.Event is definitely related to both device and there is a remote possibility it is related to procedure.
 
Manufacturer Narrative
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) 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.H10 additional narrative: added: b1, b2, h6 (patient) corrected: h6 (device) h6 patient code: no code available (3191) was used to capture joint instability, tendon rupture and surgical intervention.If information is obtained that was not available for the initial report, a follow-up report 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: corrected: h6 (device).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.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.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Review of the x-ray evidence found nothing indicative of a device nonconformance or anything indicative of a contribution to the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Added: d6a, d6b, h6 (impact, clinical and problem code) d2b, g4.
 
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Brand Name
DEPUY1 GENTAMICIN CEMENT 40G
Type of Device
BONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY CMW - 9610921
cornford rd
blackpool FY4 4 QQ
UK  FY4 4QQ
Manufacturer (Section G)
DEPUY CMW - 9610921
cornford rd
blackpool FY4 4 QQ
UK   FY4 4QQ
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9386113
MDR Text Key168458807
Report Number1818910-2019-118542
Device Sequence Number1
Product Code MBB
UDI-Device Identifier10603295174264
UDI-Public10603295174264
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/12/2019
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? Yes
Device Operator Health Professional
Device Model Number5450-31-500
Device Catalogue Number545031500
Device Lot Number8842443
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/12/2019
Initial Date FDA Received11/27/2019
Supplement Dates Manufacturer Received11/12/2019
01/10/2020
06/10/2020
06/29/2023
Supplement Dates FDA Received11/28/2019
01/16/2020
06/22/2020
06/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient SexMale
Patient Weight132 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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