MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. WRIGHT UNKNOWN PLATE; UNKNOWN HARDWARE

Catalog Number UNK_WTM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

Device not returned for evaluation.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient underwent a revision surgery 2 months post-op due to hardware pull out which allowed the humeral head to fall into varus.The failed humeral plate was explanted.

• Brand Name: WRIGHT UNKNOWN PLATE
• Type of Device: UNKNOWN HARDWARE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12467021
• MDR Text Key: 271249684
• Report Number: 0001043534-2021-00179
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 82 YR
• Patient Weight: 72