MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL ADVANTAGE STEM 8 MM; SHOULDER HUMERAL STEMS

Catalog Number 113708000

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Not Applicable (3189)

Event Date 03/13/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient experienced pain in the shoulder and surrounding regions, loss of range of motion and loosening of the components.Doi: (b)(6) 2015 : dor: (b)(6) 2017; (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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL ADVANTAGE STEM 8 MM
• Type of Device: SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7507257
• MDR Text Key: 108006972
• Report Number: 1818910-2018-59415
• Device Sequence Number: 1
• Product Code: MJT
• UDI-Device Identifier: 10603295007081
• UDI-Public: 10603295007081
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 113708000
• Device Lot Number: D14021808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2018
• Date Device Manufactured: 03/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR