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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND MOD CENT EPI 2 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
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DEPUY ORTHOPAEDICS INC US DXTEND MOD CENT EPI 2 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY Back to Search Results
Model Number 130720201
Device Problem Osseointegration Problem (3003)
Patient Problem Inadequate Osseointegration (2646)
Event Date 06/02/2021
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
The patient was revised to address periprosthetic fracture and loosening of the humeral stem at the bone to implant interface.All implants were removed and replaced with competitor products.Doi: (b)(6) 2016, dor: (b)(6) 2021, right shoulder.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
DXTEND MOD CENT EPI 2 HA
Type of Device
DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11999518
MDR Text Key256202918
Report Number1818910-2021-12667
Device Sequence Number1
Product Code HSD
UDI-Device Identifier10603295027317
UDI-Public10603295027317
Combination Product (y/n)N
PMA/PMN Number
K192855
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number130720201
Device Catalogue Number130720201
Device Lot Number5233885
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/02/2021
Initial Date FDA Received06/15/2021
Supplement Dates Manufacturer Received07/15/2021
Supplement Dates FDA Received07/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DXTEND GLENOSPHERE STD D42MM; DXTEND METAGLENE; DXTEND MODULAR HUM STEM D12 HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D42 +6MM; DXTEND GLENOSPHERE STD D42MM; DXTEND METAGLENE; DXTEND MODULAR HUM STEM D12 HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D42 +6MM
Patient Outcome(s) Required Intervention;
Patient Age57 YR
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