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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 UNKNOWN SHOULDER METAGLENE
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DEPUY FRANCE SAS - 3003895575 UNKNOWN SHOULDER METAGLENE Back to Search Results
Catalog Number UNK SHOULDER METAGLENE
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2022
Event Type  malfunction  
Event Description
It was reported that this was an rsa for treating cta on (b)(6) 2022.The glenosphere was deployed in place.The patient was x-rayed postoperatively, and a 3mm gap was found between the glenosphere and the base plate (unk).The device was brand new and the first use when the issue occurred.As of (b)(6) the patient is not supposed to undergo a revision procedure.
 
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.
 
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 this was an rsa for treating cta on (b)(6) 2022.The glenosphere was deployed in place.The patient was x-rayed postoperatively, and a 3mm gap was found between the glenosphere and the base plate (unk).The device was brand new and the first use when the issue occurred.As of (b)(6) the patient is not supposed to undergo a revision procedure.
 
Event Description
Additional information received, indicated that there were no surgical delay and adverse consequences that affected the patient.
 
Manufacturer Narrative
(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 : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
UNKNOWN SHOULDER METAGLENE
Type of Device
SHOULDER METAGLENE
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK   LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13286298
MDR Text Key286233376
Report Number1818910-2022-01128
Device Sequence Number1
Product Code KIJ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK SHOULDER METAGLENE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
DXTEND GLENOSPHERE STD D38MM
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