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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER LOCKING SCREW
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DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER LOCKING SCREW Back to Search Results
Catalog Number UNK SHOULDER LOCKING SCREW
Device Problem Osseointegration Problem (3003)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Inadequate Osseointegration (2646)
Event Date 10/12/2020
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 delta xtend shoulder prosthesis left side in 2016.Since about one year after implantation patient experienced pain.Revision because of pain on (b)(6) 2020.Intraoperatively patient tissue was found to be black.
 
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Brand Name
UNKNOWN SHOULDER LOCKING SCREW
Type of Device
SHOULDER LOCKING SCREW
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11036043
MDR Text Key222284111
Report Number1818910-2020-26842
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK SHOULDER LOCKING SCREW
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2020
Date Manufacturer Received02/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DXTEND GLENOSPHERE STD D42MM; DXTEND HIGHMO PE CUP D42 +3MM; DXTEND METAGLENE; DXTEND MOD CENT EPI 2 HA; DXTEND MODULAR HUM STEM D10 HA; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X36MM; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; DXTEND GLENOSPHERE STD D42MM; DXTEND HIGHMO PE CUP D42 +3MM; DXTEND METAGLENE; DXTEND MOD CENT EPI 2 HA; DXTEND MODULAR HUM STEM D10 HA; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X36MM; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW
Patient Outcome(s) Required Intervention;
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