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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND CTA HEAD D52 X 26MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL HEADS
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DEPUY FRANCE SAS - 3003895575 DXTEND CTA HEAD D52 X 26MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL HEADS Back to Search Results
Model Number 130752026
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Pain (1994); Pneumonia (2011); Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2020
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
Patient was treated with a right shoulder prosthetics on the (b)(6) 2020 due to an unknown reason.During recovery the patient received a closed reduction to treat a pain and instability secondary to a dislocation caused by a fall.The recovery course has been complicated by a covid infection.The patient will be revised in (b)(6) 2021 after a nickel free implant is received due to the patient's nickel allergy.
 
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.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture generalized disorder (e23).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: the device associated with this report was not received for examination.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: product/lot information is not available.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.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: product/lot information is not available.
 
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Brand Name
DXTEND CTA HEAD D52 X 26MM
Type of Device
DELTA XTEND IMPLANTS : SHOULDER HUMERAL HEADS
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key11089436
MDR Text Key224252502
Report Number1818910-2020-27487
Device Sequence Number1
Product Code KWS
UDI-Device Identifier10603295027720
UDI-Public10603295027720
Combination Product (y/n)N
PMA/PMN Number
K062250
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number130752026
Device Catalogue Number130752026
Was Device Available for Evaluation? No
Date Manufacturer Received07/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CTM DELTA GLENOSPHERE STD D42:SS8495/9553769; DXTEND CTA HEAD D52 X 26MM; DXTEND HUMERAL SPACER +9MM; DXTEND MOD CENT EPI 1 HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND STAND PE CUP D42 +6MM; GLOBAL UNITE STD STEM SZ 12; METAGLENE +10MM; UNK SHOULDER GLENOSPHERE DELTA XTEND; UNK SHOULDER HUMERAL CUP DELTA XTEND; UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND; UNK SHOULDER HUMERAL STEM DELTA XTEND; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW
Patient Outcome(s) Required Intervention;
Patient Age83 YR
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