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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 DXTEND MBLOC HUM EPI 2 D10 STD; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
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DEPUY FRANCE SAS 3003895575 DXTEND MBLOC HUM EPI 2 D10 STD; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS Back to Search Results
Catalog Number 130710200
Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 05/24/2019
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.
 
Event Description
Removal of infected shoulder prosthesis, surgeon, (b)(6) hospital (b)(6) 2019.History of painful shoulder.Clinical markers indicate infection, according to surgeon.All components removed, which were quite loose (both humeral and glenoid), then discarded.Biomet shoulder antibiotic cement spacer placed insitu.
 
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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Remove loosening code on the cup and add loosening for the humerus.
 
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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch 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.Product complaint #: (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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
DXTEND MBLOC HUM EPI 2 D10 STD
Type of Device
DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
Manufacturer (Section D)
DEPUY FRANCE SAS 3003895575
7 allée irène joliot curie
bp 256
saint priest cedex IN 69801
FR  69801
MDR Report Key8696964
MDR Text Key147931900
Report Number1818910-2019-95914
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number130710200
Device Lot Number5218462
Was Device Available for Evaluation? No
Date Manufacturer Received08/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
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