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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); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 07/15/2020
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
It was reported that during a shoulder prothesis revision there was a delay of surgery with a delta xtend prothesis.The implant was broken and the surgeon had removed the device.The implantation date: 2016.
 
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: b5.Corrected: g1.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 stated that the patient experienced pain for about 18 months, functional impotence and lameness.X-ray result revealed disassembly of the glenoid sphere.There was a surgical delay of 60 minutes.
 
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.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - examination of the returned devices confirmed the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: d11.Corrected: h3.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned devices confirmed the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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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 Key10401311
MDR Text Key202709703
Report Number1818910-2020-18029
Device Sequence Number1
Product Code HSD
UDI-Device Identifier10603295027775
UDI-Public10603295027775
Combination Product (y/n)N
PMA/PMN Number
D165018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number130760142
Device Catalogue Number130760142
Device Lot Number5248041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2020
Date Manufacturer Received09/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DXTEND METAGLENE; DXTEND METAGLENE; DXTEND MODULAR HUM STEM D14 HA; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW NO LOCK D4.5X24MM; DXTEND STAND PE CUP D42 +3MM; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; DXTEND MODULAR HUM STEM D14 HA; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW NO LOCK D4.5X24MM; DXTEND STAND PE CUP D42 +3MM; UNKNOWN SHOULDER METAGLENE
Patient Outcome(s) Required Intervention;
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