MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN BIGLIANI/FLATOW GLENOID; SHOULDER PROSTHESIS

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No devices or photos were received; therefore, the condition of the components is unknown.Device history records cannot be reviewed since the part and lot numbers are unknown.These devices are used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Product history search cannot be completed and compatibly cannot be verified since the part and lot numbers are unknown.Patient¿s adherence to rehabilitation protocol is unknown.A definite root cause cannot be determined with the information provided.

Event Description

It is reported that superior migration of the humeral head consistent with superior subluxation was noted radiographically for 14 patients.

• Brand Name: UNKNOWN BIGLIANI/FLATOW GLENOID
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5822584
• MDR Text Key: 50445305
• Report Number: 0001822565-2016-02579
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• 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