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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND GLENOSPHERE STD D42MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
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DEPUY FRANCE SAS - 3003895575 DXTEND GLENOSPHERE STD D42MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE Back to Search Results
Model Number 130760142
Device Problems Fracture (1260); Difficult to Insert (1316); Device-Device Incompatibility (2919)
Patient Problem Not Applicable (3189)
Event Date 03/12/2020
Event Type  malfunction  
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
During the delta xtend reverse shoulder replacement we had trouble getting the glenosphere implant attached to the metaglene base plate.When we inspected the base plate after, it appeared to be cross threaded.We then tried a new glenosphere and we then couldn't get this to attach either.We then removed the metaglene base plate and implanted a new one as the thread in the metalglene must have been cross threaded too.After the new metaglene was implanted we then implanted the second glenosphere successfully (which has the same lot number as the one which we failed to implant) to the base plate.The same screws were used.The implants which were not implanted are being decontaminated and will be returned for inspection.The surgeon mentioned that it may have been an alignment issue.
 
Manufacturer Narrative
Product complaint # (b)(4).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: examination of the returned devices could not confirm the reported event.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: the dhr analysis of the batches indicated shows an initial conformance of these products with regards to their specification.For these batches, there was no deviation or non-conformance.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).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.
 
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Brand Name
DXTEND GLENOSPHERE STD D42MM
Type of Device
DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key9911120
MDR Text Key214801722
Report Number1818910-2020-09878
Device Sequence Number1
Product Code HSD
UDI-Device Identifier10603295027775
UDI-Public10603295027775
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 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number130760142
Device Catalogue Number130760142
Device Lot Number5341880
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2020
Date Manufacturer Received04/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DXTEND GLENOSPHERE STD D42MM; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X18MM
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