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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL HEADS
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DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL HEADS Back to Search Results
Catalog Number UNK SHOULDER HUMERAL HEAD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 08/04/2020
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
The patient was revised to address rotator cuff tore.Doi: unknown.Dor: (b)(6) 2020.Affected side: left 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.
 
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Brand Name
UNKNOWN SHOULDER HUMERAL HEADS
Type of Device
SHOULDER HUMERAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10436168
MDR Text Key203822611
Report Number1818910-2020-18502
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK SHOULDER HUMERAL HEAD
Was Device Available for Evaluation? No
Date Manufacturer Received08/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN SHOULDER GLENOID; UNKNOWN SHOULDER HUMERAL BODY; UNKNOWN SHOULDER GLENOID; UNKNOWN SHOULDER HUMERAL BODY
Patient Outcome(s) Required Intervention;
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