MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL ADVANTAGE STEM 10 MM; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL STEMS

Model Number 1137-10-000

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/19/2020

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 of global advantage total - stem, head and glenoid anchor peg due to infection.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received stating that it was confirmed that there has only been 1 revision procedure on (b)(6) 2020.The reason was for infection and rotator cuff failure.Loosening of the stem was noted during extraction, but the reason for it was not given buy the surgeon.A cement spacer was implanted during this procedure and a second procedure is planned where a competitor system (reverse shoulder) will be implanted.

Event Description

Affected side was the left shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot - the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: b5.

• Brand Name: GLOBAL ADVANTAGE STEM 10 MM
• Type of Device: GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10967863
• MDR Text Key: 220190433
• Report Number: 1818910-2020-26426
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295007111
• UDI-Public: 10603295007111
• Combination Product (y/n): N
• PMA/PMN Number: K992065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1137-10-000
• Device Catalogue Number: 113710000
• Device Lot Number: WJ6BJ1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/17/2020; 02/03/2021
• Supplement Dates FDA Received: 12/24/2020; 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLOBAL ADVANTAGE HUM HD 40X21.; GLOBAL ADVANTAGE PEG GLENOID.; GLOBAL ADVANTAGE HUM HD 40X21; GLOBAL ADVANTAGE PEG GLENOID
• Patient Outcome(s): Required Intervention