MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TRABECULAR METAL REVERSE SHOULDER BASE PLATE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Unspecified Infection (1930)

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.This is 1 of 6 mdrs for the same event.Reference 1822565-2017-00314 / 00315, 9613350-2016-01210-2, 9613350-2017-00075 / 00077 / 00079.

Event Description

It is reported that the patient was revised due to baseplate loosening approximately twelve months post-operatively.Intra-operatively, infection was also noted.All components were removed and replaced with cement spacer molds.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint device was not received for evaluation; however, the reported event was confirmed.An x-ray review was performed and confirmed the alleged loosening.The surgical report of implantation stated that, ¿a free articulation without conspicuous notching with good tension.¿ the diagnosis was secondary arthrosis associated with the lesions of the rotator cuff.There was an indication of pain and a dysfunctional rotator cuff deficiency.During the surgery, an omarthrosis was found and arthrosis on the glenoid.The report also describes that the patient had significant osteoporosis.Finally, free articulation without conspicuous notching with good tension was achieved.The device history records were reviewed and no discrepancies were identified.A review of the complaint history determined that no further action is required.A definite root cause cannot be determined with the information provided.A summary of the investigation has been sent to the complainant.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.

• Brand Name: ZIMMER TRABECULAR METAL REVERSE SHOULDER BASE PLATE
• 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: 6274603
• MDR Text Key: 65663829
• Report Number: 0001822565-2017-00314
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK130661
• 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,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• 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: 00434901500
• Device Lot Number: 63020763
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2015
• 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 Weight: 53