MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HUMERAL TRAY; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Loss of Range of Motion (2032); Ambulation Difficulties (2544)

Event Date 09/09/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 211260, compr srs mod stem - 9 x 150 mm, 878780.Unknown, unknown glenoshpere, unknown.The 211218, compr srs prox bdy - lg 42 mm, 258120.Unknown, unknown humeral bearing, unknown.Unknown, unknown baseplate, unknown.Unknown, unknown central screw, unknown.Unknown, unknown peripheral screw, unknown.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the part and lot numbers of the device involved in the event are unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01437, 0001825034-2018-04090, 0001825034-2018-01436, 0001825034-2018-04092, 0001825034-2018-04093, 0001825034-2018-04094, 0001825034-2018-04095.

Event Description

It was reported that the patient underwent a right shoulder surgery due to a neck fracture.Patient underwent a surgery for debridement due to infection and septic loosening.As part of this study, the patient underwent a right shoulder revision procedure.It was reported that the patient suffered dislocation and subluxation of the prosthesis.The patient underwent hematoma evacuation and implant reduction as part of treatment.Subsequently, during a six month, one year, and three year follow-up, the patient reported being unable to open a jar, difficulty with heavy chores and recreational activities, washing back, and difficulty carrying bag and using a knife.The shoulder has caused moderately limited social life and work.Patient also noted for all three follow ups that there was no arm, shoulder, or hand pain.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN HUMERAL TRAY
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7611522
• MDR Text Key: 111399972
• Report Number: 0001825034-2018-04091
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2014
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 83