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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MOD CENT EPI 1 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
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DEPUY FRANCE SAS - 3003895575 DXTEND MOD CENT EPI 1 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY Back to Search Results
Model Number 130720101
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 02/19/2020
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
The patient was revised to address aseptic loosening of the humeral stem at the bone to implant interface.The reference number recorded from the stem isn¿t registering with the system, but it is thought to be a size 10 standard global unite stem.Implant information is available.Doi: unknown; dor: (b)(6) 2020; left shoulder.
 
Additional 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. .
 
Additional 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 associated with this report was received for examination.X-ray and photographs were unable to confirm the reported event as well.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 MOD CENT EPI 1 HA
Common Device Name
DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key9813624
Report Number1818910-2020-07378
Device Sequence Number2815531
Product Code KWS
UDI-Device Identifier10603295027287
UDI-Public10603295027287
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date (Section B) 02/19/2020
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
Operator of Device Health Professional
Device Model Number130720101
Device Catalogue Number130720101
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/19/2020
Supplement Date Received by Manufacturer02/26/2020
04/09/2020
Initial Report FDA Received Date03/10/2020
Supplement Report FDA Received Date03/17/2020
04/09/2020
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 HUMERAL SPACER +9MM; DXTEND HUMERAL SPACER +9MM; DXTEND MOD CENT EPI 1 HA; DXTEND STAND PE CUP D42 +3MM; DXTEND STAND PE CUP D42 +3MM; UNK SHOULDER GLENOSPHERE; UNK SHOULDER LOCKING SCREW; UNK SHOULDER LOCKING SCREW; UNK SHOULDER METAGLENE; UNK SHOULDER NON-LOCKING SCREW; UNK SHOULDER NON-LOCKING SCREW; UNKNOWN PIN GUIDES; UNKNOWN SHOULDER HUMERAL STEM; UNKNOWN SHOULDER HUMERAL STEM
Outcome Attributed to Adverse Event Required Intervention;
Patient Weight79
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