MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 DXTEND GLENOSPHERE STD D38MM; SHOULDER GLENOSPHERE

Catalog Number 130760138

Device Problems Fitting Problem (2183); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2018

Event Type  malfunction  

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

During implantation, surgeon decided components where not in the right position so opted to remove them and replace with new ones as taper wasn't engaging - user error.No ae to patient.(unknown jrn = (b)(4) locking screw 34mm/lot # unknown/product discarded) doe: (b)(6) 2018.

Manufacturer Narrative

Product complaint # pc- (b)(4).Investigation summary examination of the affected products was not possible because the products were not returned.Based on the investigation performed no product problem 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.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 D38MM
• Type of Device: SHOULDER GLENOSPHERE
• 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 rd.; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7330437
• MDR Text Key: 102105895
• Report Number: 1818910-2018-54868
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027768
• UDI-Public: 10603295027768
• 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: foreign,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130760138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2018
• 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