MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SHOULDER PRIMARY STEM MICRO LENGTH; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Comp rvrs 25mm bsplt ha+adptr pn010000589 ln577550; comp rvs tray co 44mm pn115370 ln705190; comp rvrs shldr glnsp +6 41mm pn115326 ln112680; acrom xl 44-41 std hmrl brng pnxl-115366 ln478650.Complaint op notes state that the humeral component was grossly loose therefore the reported event is confirmed.No device was returned for evaluation, therefore, no visual or dimensional inspections were conducted.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.However, the complaint may be revised upon return of device or further information.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.

Event Description

It was reported that the patient underwent an initial right reverse total shoulder arthroplasty.Subsequently the patient was revised due to aseptic loosening of the humeral component 5 months later.

• Brand Name: COMPREHENSIVE SHOULDER PRIMARY STEM MICRO LENGTH
• 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: 7386373
• MDR Text Key: 104026808
• Report Number: 0001825034-2018-02121
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 113608
• Device Lot Number: 704170
• Other Device ID Number: (01) 0 0880304 55409 2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR