MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND STAND PE CUP D42 +3MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Model Number 130742203

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Health effect - clinical code: appropriate term / code not available (e2402) used to capture the infection (e19).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 infection of spinal hardware/shoulder implants.Surgeon removed all shoulder implants and out in an antibiotic spacer.Upon opening the joint he found traces of metaloasis, surgeon was unsure what caused it.The glenosphere was loose and pulled out with a ronguer.The metaglene baseplate and screws all came out with the glenosphere.The inferior locking screw was broken midway on the screw.No further patient information is available at this time.Doi: (b)(6) 2017, dor: (b)(6) 2020, right shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed corrected: d3, g1.

• Brand Name: DXTEND STAND PE CUP D42 +3MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 11117471
• MDR Text Key: 225091328
• Report Number: 1818910-2021-00221
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295027539
• UDI-Public: 10603295027539
• Combination Product (y/n): N
• PMA/PMN Number: K120174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 130742203
• Device Catalogue Number: 130742203
• Device Lot Number: 5281701
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND GLENOSPHERE STD D42MM.; DXTEND METAGLENE.; DXTEND MOD CENT EPI 1 HA.; DXTEND MODULAR HUM STEM D12 HA.; DXTEND SCREW LOCK D4.5X30MM.; DXTEND SCREW LOCK D4.5X30MM.; DXTEND SCREW NO LOCK D4.5X18MM.; DXTEND SCREW NO LOCK D4.5X18MM.; DXTEND GLENOSPHERE STD D42MM; DXTEND METAGLENE; DXTEND MOD CENT EPI 1 HA; DXTEND MODULAR HUM STEM D12 HA; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X18MM
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 121