MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND SCREW LOCK D4.5X30MM; DELTA XTEND IMPLANTS : SCREWS

Catalog Number 130790030

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 10/12/2020

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

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.Surgeon is suspecting a low grade infection; there were no signs of metal wear that would have caused the black tissue.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.

Event Description

The patient was revised on (b)(6) 2020 to address "loosening of shoulder tep", with severe metallosis, pronounced chronic fibrosing and scarring inflammation with metallosis.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned device could not confirm the reported event.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.Corrected: h3.

• Brand Name: DXTEND SCREW LOCK D4.5X30MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex ; EI
• MDR Report Key: 10741829
• MDR Text Key: 213248653
• Report Number: 1818910-2020-23392
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 130790030
• Device Lot Number: 5297477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2020
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK SHOULDER GLENOSPHERE DELTA XTEND.; UNK SHOULDER HUMERAL CUP DELTA XTEND.; UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND.; UNK SHOULDER HUMERAL STEM DELTA XTEND.; UNKNOWN SHOULDER LOCKING SCREW.; UNKNOWN SHOULDER LOCKING SCREW.; UNKNOWN SHOULDER LOCKING SCREW.; UNKNOWN SHOULDER LOCKING SCREW.; UNKNOWN SHOULDER METAGLENE.; UNKNOWN SHOULDER NON-LOCKING SCREW.; UNKNOWN SHOULDER NON-LOCKING SCREW.; UNK SHOULDER GLENOSPHERE DELTA XTEND; UNK SHOULDER HUMERAL CUP DELTA XTEND; UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND; UNK SHOULDER HUMERAL STEM DELTA XTEND; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR