MAUDE Adverse Event Report: ZIMMER, INC. BIGLIANI/FLATOW MODULAR HUMERAL STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No device or photos were received; therefore the condition of the device is unknown.The device history records were reviewed and no discrepancies relevant to the reported event were found.A review of the complaint history determined that no further action is required as no trends were identified.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A root cause was unable to be determined.Concomitant medical products - bigliani/flatow modular humeral head catalog #: 00430004624 lot #: 61168543, cable-ready cerclage cable with crimp catalog #: 00223200118 lot #: 61365983, bigliani/flatow pegged glenoid component catalog #: 00430205246 lot #: 60776591.This report is number 1 of 5 mdrs filed for the same patient (reference 0001822565-2017-02210, 0001822565-2017-02211, 0001822565-2017-02214, 0001822565-2017-02215).

Event Description

It is reported that the patient is indicated for a left shoulder arthroplasty revision due to a non-functional rotator cuff approximately eight years post-operatively.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: BIGLIANI/FLATOW MODULAR HUMERAL STEM
• Type of Device: PROSTHESIS, SHOULDER
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6487009
• MDR Text Key: 72606316
• Report Number: 0001822565-2017-02208
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK982981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00430001213
• Device Lot Number: 60993797
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2008
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 76