MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND STAND PE CUP D38 +3MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Model Number 130738203

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).It was confirmed that the wear that was caused by the grade 4 scapular notching affected the polyethylene humeral cup and the inferior screw (only).Given that medical literature considers that a primary cause of scapular notching is the non-anatomic physical contact of the humeral cup against the inferior scapula bone during normal rsa shoulder function, resulting in notching of the bone, with eventual contact of the humeral cup with the inferior metaglene screw if left unaddressed, it is reasonable to consider the screw wear noted in this case as entirely secondary to the wearing caused by the humeral cup.The follow-up confirmed that only the inferior screw was affected by the humeral cup wearing through the scapula.Therefore, only the humeral cup will be reported for this adverse event.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Delta extend implants explanted from patient due to grade 4 notching causing bone loss and excessive poly wear.Wear was only on poly cup and inferior screw from notching.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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.H10 additional narrative: added: b2 (product problem), b5 corrected: d3, g1.

Event Description

Affected side is right shoulder.

• Brand Name: DXTEND STAND PE CUP D38 +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: 11027160
• MDR Text Key: 222024871
• Report Number: 1818910-2020-27140
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027362
• UDI-Public: 10603295027362
• Combination Product (y/n): N
• PMA/PMN Number: K062250
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130738203
• Device Catalogue Number: 130738203
• Device Lot Number: 5309172
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND GLENOSPHERE ECC D38MM.; DXTEND METAGLENE.; DXTEND MOD CENT EPI 1 HA.; DXTEND MODULAR HUM STEM D10 HA.; DXTEND SCREW LOCK D4.5X24MM.; DXTEND SCREW LOCK D4.5X36MM.; DXTEND SCREW NO LOCK D4.5X18MM.; DXTEND SCREW NO LOCK D4.5X18MM.; DXTEND GLENOSPHERE ECC D38MM; DXTEND METAGLENE; DXTEND MOD CENT EPI 1 HA; DXTEND MODULAR HUM STEM D10 HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X18MM
• Patient Outcome(s): Required Intervention