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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND MBLOC HUM EPI 1 D10 STD; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
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DEPUY ORTHOPAEDICS INC US DXTEND MBLOC HUM EPI 1 D10 STD; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS Back to Search Results
Model Number 130710100
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 06/22/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Patient had removal of delta xtend prosthesis due to infection.Original implantation done back in 2013.Dos: (b)(6) 2013.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.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.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).A manufacturing records evaluation (mre) was not performed.
 
Event or Problem Description
Additional information received indicated that everything was removed due to infection.There was no extension to the surgical time as this was a revision surgery.
 
Additional 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.
 
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Brand Name
DXTEND MBLOC HUM EPI 1 D10 STD
Common Device Name
DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12143107
Report Number1818910-2021-14865
Device Sequence Number4169642
Product Code HSD
UDI-Device Identifier10603295027133
UDI-Public10603295027133
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K120174
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date (Section B) 06/22/2021
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? No
Operator of Device Health Professional
Device Model Number130710100
Device Catalogue Number130710100
Device Lot Number5215174
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/22/2021
Supplement Date Received by Manufacturer07/22/2021
08/10/2021
Initial Report FDA Received Date07/09/2021
Supplement Report FDA Received Date07/28/2021
08/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
DXTEND GLENOSPHERE STD D42MM; DXTEND HIGHMO PE CUP D42 +3MM; DXTEND MBLOC HUM EPI 1 D10 STD; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW NO LOCK D4.5X24MM; DXTEND SCREW NO LOCK D4.5X24MM; DXTEND GLENOSPHERE STD D42MM; DXTEND HIGHMO PE CUP D42 +3MM; DXTEND MBLOC HUM EPI 1 D10 STD; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW NO LOCK D4.5X24MM; DXTEND SCREW NO LOCK D4.5X24MM
Outcome Attributed to Adverse Event Required Intervention;
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