MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP HUMERAL HD 40X18 ECC; GLOBAL AP IMPLANTS : SHOULDER HUMERAL HEADS

Catalog Number	113040610
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	01/12/2018
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
Revision anatomical tsr dr (b)(6), (b)(6) hospital, (b)(6) 2018.Primary performed by a different surgeon, (b)(6) 2008.Patient complained of 12 months of mild shoulder pain.Shoulder arthroscopy performed 2 weeks ago & glenoid noted to be loose.Pathology notes increased crp & staph.Infection.Surgeon removed glenoid, head and then stem with taper attached, as stem was loose.Synovial tissue & glenoid component sent off by surgeon to be cultured.Implanting new stem, taper and head.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: GLOBAL AP HUMERAL HD 40X18 ECC
• Common Device Name: GLOBAL AP IMPLANTS : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7233886
• Report Number: 1818910-2018-52546
• Device Sequence Number: 13808987
• Product Code: HSD
• UDI-Device Identifier: 10603295005698
• UDI-Public: 10603295005698
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 113040610
• Device Lot Number: B76AP1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 12/03/2018
• 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