MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 DXTEND METAGLENE; DELTA XTEND IMPLANTS : SHOULDER METAGLENE

Catalog Number 130760000

Device Problems Defective Component (2292); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

During a dleta xtend (reverse shoulder replacement) procedure, prof vrettos had difficulty engaging the thread of the 42mm glenosphere into the thread of the metaglene.After inspection of the glenosphere, he noticed that the thread was damaged, he then tried to use the 38mm glenosphere but this too wouldn't engage properly which meant the thread in the metaglene was damaged.He then opted to remove the metaglene and insert a new one and then use a new new 42mm glenosphere.This then worked.Whether the thread was damaged due to surgical error or not, this is unknown.Prof vrettos has done many of these operations and he has said that this has only happened once before, many years ago.Patient consequence? :yes.Patient consequence description:extend operating time by 30mins.Action taken for procedure:new implants were ordered and delivered.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Event Description

Date of implantation: (b)(6) 2018.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary : 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 dhr analysis of the batches indicated shows an initial conformance of these products with regards to their specification.For these batches, there was no deviation or non-conformance.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DXTEND METAGLENE
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cede 69801 ; FR 69801
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; b.p. 256; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6103142063
• MDR Report Key: 7619643
• MDR Text Key: 111688506
• Report Number: 1818910-2018-62657
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027737
• UDI-Public: 10603295027737
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130760000
• Device Lot Number: 5305840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR