MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL ANCHOR PEG GLENOID 44MM; SHOULDER GLENOID

Catalog Number	113641025
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Primary surgery date (b)(6) 2007.Revision for: pain and instability due to a lose glenoid component.The surgeon stated that the glenoid component was lose and had to be removed.The patients rotator cuff tendon had to be repaired during the revision surgery.The surgeon replaced the explanted with the same size new implants.Doi: (b)(6) 2007 dor: (b)(6) 2018 unknown shoulder.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Investigation summary: no device associated with this report was received for examination.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: GLOBAL ANCHOR PEG GLENOID 44MM
• Common Device Name: SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7305855
• Report Number: 1818910-2018-54340
• Device Sequence Number: 16482529
• Product Code: KWS
• UDI-Device Identifier: 10603295006961
• UDI-Public: 10603295006961
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K981487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 113641025
• Device Lot Number: AV7AN1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 06/06/2018; 11/09/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 06/18/2018; 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR