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

Catalog Number 130742203

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 03/21/2018

Event Type  Injury  

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

Revision reverse shoulder replacement.Surgeon: (b)(6), (b)(6) private primary shoulder was a global adv, revised to delta xtend for infection on the (b)(6) 2015 this was the revision of the delta.Revision (b)(6) 2018 for inferior notching, poly wear - leading to pain.Patient initial (b)(6).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: product code: 130742203, lot number 5247633.Device history review: review of the device history records did not reveal any related manufacturing deviations or anomalies that would have contributed to the reported event.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

• 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 allée irène joliot curie; bp 256; saint priest cedex 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, IN 19380-0988 ; 6103142063
• MDR Report Key: 7439463
• MDR Text Key: 105769846
• Report Number: 1818910-2018-57593
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027539
• UDI-Public: 10603295027539
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K062250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 130742203
• Device Lot Number: 5247633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• Date Device Manufactured: 04/07/2015
• 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 Outcome(s): Required Intervention