MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE HEAD 40X15 STD; SHOULDER HEAD/GLENOSPHERE

Catalog Number	110040500
Medical Device Problem Codes	Disassembly (1168); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Synovitis (2094); No Information (3190)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 following a fracture of a global unite head.Update july 4, 2017: additional information received indicating the patient was revised due to disassembly of the head.Doi updated and added patient demographics.Part and lot numbers are added into the complaint record.This complaint was updated on july 4, 2017.Update july 31, 2017: additional information received indicating the patient underwent surgical revision with joint synovectomy and change of head and humeral metaphysis.It was reported that there is synovitis with metallosis at the glenoid.This complaint was updated on july 31, 2017.
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
Product complaint #:(b)(4).Investigation summary : investigation of the reported event confirmed the reported device disassociation.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot :product code (b)(4).Device history review :review of the device history records did not reveal any related manufacturing deviations or anomalies.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > investigation of the reported event confirmed the reported device disassociation.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = > product code 110040500, lot number 537273.Device history review = > review of the device history records did not reveal any related manufacturing deviations or anomalies.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL UNITE HEAD 40X15 STD
• Common Device Name: SHOULDER HEAD/GLENOSPHERE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6760527
• Report Number: 1818910-2017-22073
• Device Sequence Number: 10913638
• Product Code: HSD
• UDI-Device Identifier: 10603295004479
• UDI-Public: 10603295004479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/31/2017

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: 110040500
• Device Lot Number: 537273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 07/31/2017; 07/31/2017; 04/23/2017; 04/23/2018
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 08/15/2017; 08/16/2017; 04/27/2018; 05/02/2018
• 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: 62 YR
• Patient Weight: 40