MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number 1100-40-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/18/2021

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

The patient's shoulder was revised due to tuberosity fractured off.Doi: (b)(6) 2020, dor: (b)(6) 2021, right shoulder.

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.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.

• Brand Name: GLBL UNITE ANT BODY 135 SZ 12
• Type of Device: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11628391
• MDR Text Key: 244223231
• Report Number: 1818910-2021-07289
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004417
• UDI-Public: 10603295004417
• Combination Product (y/n): N
• PMA/PMN Number: K170748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1100-40-000
• Device Catalogue Number: 110040000
• Device Lot Number: 9411697
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CROSSLINK ANCHOR PG GLENOID 44; GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE HEAD 44X21 STD; CROSSLINK ANCHOR PG GLENOID 44; GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE HEAD 44X21 STD
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR