MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 DXTEND STAND PE CUP D42 +3MM; SHOULDER BEARING

Catalog Number 130742203

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 10/19/2017

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

Der states that the screw in glenosphere broke leaving part of screw in metaglene and glenosphere disassociated from metaglene.(b)(6) 2018 upon review of the finalized evaluation, the reported dxtend stand pe cup d42 +3mm was noted to be worn.Product failure has been updated in implant bearing wear-polyethylene.Ay.

Manufacturer Narrative

The complaint description states that the screw in glenosphere broke leaving part of screw in metaglene and glenosphere disassociated from metaglene.Examination of the returned device(s) confirms the reported event.Product problem has not been identified.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.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: SHOULDER BEARING
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 7198972
• MDR Text Key: 97491231
• Report Number: 1818910-2018-10058
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027539
• UDI-Public: 10603295027539
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• 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: 5267998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2016
• 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: 72 YR
• Patient Weight: 93