MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND GLENOSPHERE STD D42MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Catalog Number 130760142

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Not Applicable (3189)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

Direction of the set screw was reversed (upside down) when opened brand new package.

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.

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

• Brand Name: DXTEND GLENOSPHERE STD D42MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 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; b.p. 256; west chester, PA 19380-XXXX ; 6103142063
• MDR Report Key: 8074146
• MDR Text Key: 127281338
• Report Number: 1818910-2018-75635
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295027775
• UDI-Public: 10603295027775
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130760142
• Device Lot Number: 5266471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• 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