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

Catalog Number 130742003

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 02/07/2018

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

Revision reverse total shoulder replacement, dr (b)(6), (b)(6) hospital (b)(6) 2018.Primary implant date: (b)(6) 2015.Revision reverse shoulder replacement was performed due to patient presenting to surgeon with pain.The glenosphere and humeral liner were exchanged due to ware noted on inferior edge of liner.The inferior screw was removed and replaced with a shorter screw due to inferior screw length was noted to be to long.Male patient initials ta, aged (b)(6) years, dob: (b)(6).Doi: (b)(6) 2015; dor: (b)(6) 2018; unk shoulder.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no products were returned for this complaint.Based on the investigation performed no product defect was identified.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 batch (b)(4)/ product code: (b)(4), shows an initial conformance of these products with regards to the specification.For this batch, there was no deviation or non-conformance.30 parts were manufactured in (b)(4) 2015.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DXTEND HIGHMO 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; b.p. 256; : saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; bp 256; leeds 69801 ; UK 69801
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7319757
• MDR Text Key: 101690511
• Report Number: 1818910-2018-54647
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K073676
• 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: 02/07/2018

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 Catalogue Number: 130742003
• Device Lot Number: 5250698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 09/06/2018
• Date Device Manufactured: 05/11/2015
• 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
• Patient Age: 67 YR