Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND HIGHMO PE CUP D42 +6MM; SHOULDER HUMERAL CUP
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US DXTEND HIGHMO PE CUP D42 +6MM; SHOULDER HUMERAL CUP Back to Search Results
Catalog Number 130742006
Device Problem Naturally Worn (2988)
Patient Problem Insufficient Information (4580)
Event Date 06/08/2021
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
Revision surgery required due to a broken screw of the glenosphere.Also clear erosion of the pe cup due to scapular contact.The patient had a reversed delta xtend prosthesis of 7 yo.
 
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).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 there was no surgical delay.
 
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.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DXTEND HIGHMO PE CUP D42 +6MM
Type of Device
SHOULDER HUMERAL CUP
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12063188
MDR Text Key258223923
Report Number1818910-2021-13540
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 06/10/2021
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 Catalogue Number130742006
Device Lot Number5230704
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2021
Initial Date Manufacturer Received 06/10/2021
Initial Date FDA Received06/24/2021
Supplement Dates Manufacturer Received06/17/2021
06/29/2021
08/31/2021
Supplement Dates FDA Received06/28/2021
07/10/2021
09/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DXTEND GLENOSPHERE STD D42MM; UNKNOWN SHOULDER HUMERAL CUP; DXTEND GLENOSPHERE STD D42MM; UNKNOWN SHOULDER HUMERAL CUP
Patient Outcome(s) Required Intervention;
Patient Age7 YR
-
-