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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL STEMS
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DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL STEMS Back to Search Results
Catalog Number UNK HUMERAL STEM
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Loss of Range of Motion (2032); Discomfort (2330)
Event Date 07/28/2021
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
Patient received a shoulder revision on (b)(6) 2021 to treat discomfort and dissatisfaction with the initial implant due to rom issues.The stem and humeral epiphysis were revised.The cement utilized in the primary procedure was a competitor product.No additional information is available.Doi: unk.Dor: (b)(6) 2021.Right shoulder.
 
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.H6 medical device problem code: appropriate term / code not available (a27) used to capture customer feedback: dissatisfaction.
 
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Brand Name
UNKNOWN SHOULDER HUMERAL STEMS
Type of Device
SHOULDER HUMERAL STEMS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12431893
MDR Text Key270050863
Report Number1818910-2021-19330
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
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK HUMERAL STEM
Was Device Available for Evaluation? No
Date Manufacturer Received10/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COMPETITOR CEMENT; DXTEND MBLOC HUM EPI 2 D12 STD; UNK SHOULDER HUMERAL STEM DELTA XTEND; COMPETITOR CEMENT; DXTEND MBLOC HUM EPI 2 D12 STD; UNK SHOULDER HUMERAL STEM DELTA XTEND
Patient Outcome(s) Required Intervention;
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