MAUDE Adverse Event Report: ZIMMER LEFT SHOULDER REPLACEMENT KIT

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problem Pulmonary Edema (2020)

Event Date 06/03/2015

Event Type  Other  

Event Description

Caller stated a week after his initial surgery he had a revision due to his screws having failed.About two weeks later, caller reported he was admitted to the hospital for several days to treat his pulmonary edema.While in the hospital, caller stated staff found that his shoulder was dislocated.He has reported the incident to zimmer and is now awaiting a letter from them so he can proceed to have another revision.

• Brand Name: LEFT SHOULDER REPLACEMENT KIT
• Type of Device: LEFT SHOULDER REPLACEMENT KIT
• Manufacturer (Section D): ZIMMER; warsaw IN
• MDR Report Key: 5075149
• MDR Text Key: 25773021
• Report Number: MW5056117
• Device Sequence Number: 1
• Product Code: HSD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 91