MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE HUMERAL STEM¿MINI; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Material Disintegration (1177); Migration (4003)

Patient Problem No Information (3190)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: humeral tray [115378, 080650]; humeral bearing [ep-115393,705570]; versa-dial glenosphere standard 36 mm [115310; lot 247930] ; central screw 6.5 mm 3.5 hex 30 mm length [115396; lot 492050] ; fixed locking screw 4.75 mm 3.5 hex 30 mm length [180553; lot 642760] ; fixed locking screw 4.75 mm 3.5 hex 35 mm length [180554; lot 135720] ; comprehensive mini baseplate and taper adaptor 25 mm [010000589; lot 082010] ; fixed locking screw [180550; lot 808750] ; fixed locking screw [180550; lot 084440].Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports:0001825034 - 2018 - 05113 not returned to manufacturer.

Event Description

It was reported the patient underwent a left reverse total shoulder arthroplasty revision due to humeral stem loosening/subsidence.During the revision, metallic wear debris and inflamed tissue was noted in the joint.The humeral tray was also noted to be dislodged.No additional patient consequences were reported.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Reported event was confirmed by review of the operative notes.As per initial, 1st revision and 2nd revision operative notes, the patient was a tobacco user, had poor nutrition, and diabetes.The patient also has a below knee amputation.The patient was forced to stop nicotine, has hardly any body fat, and deltoid tissue was noted to be thin with questionable function.Extensive scar tissue was present from multiple surgeries.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE HUMERAL STEM¿MINI
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7785159
• MDR Text Key: 117192450
• Report Number: 0001825034-2018-05112
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113630
• Device Lot Number: 495340
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR