MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 UNKNOWN SHOULDER GLENOID

Catalog Number UNK SHOULDER GLENOID

Device Problem Naturally Worn (2988)

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

Event Date 05/14/2018

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 s-fit and global advantage shoulder replacement, dan posel, lake macquarie private (b)(6) 2018.Primary implant date: (b)(6) 2004.S-fit glenoid use with global advantage stem for anatomical shoulder replacement 14 years ago.Patient experienced pain onset and was advised to revise due to rotator cuff deficiency.There was poly wear and glenoid wear to the point where there was metal on metal with the prosthesis.Revised all implants, with delta xtend reverse shoulder.Relevant patient pre-existing conditions/ comorbidities: rotator cuff deficiency.Patient initial t.Aged 80 years.Unknown jrn: (b)(4) s-fit glenoid bearing 44x3, lot # 1141284; unknown jrn: (b)(4) s-fit mb glenoid 44mm, lot # ymv-40; unknown jrn: no product code - 3.5x28 screws, for s-fit - lot # unknown.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: UNKNOWN SHOULDER GLENOID
• Type of Device: SHOULDER GLENOID
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cede 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: 7596597
• MDR Text Key: 110910420
• Report Number: 1818910-2018-62076
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOID
• Device Lot Number: YMV-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• Date Device Manufactured: 02/25/2003
• 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: 80 YR