MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE MD HYBRID GLENOID BASE 4MM; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problems Unintended System Motion (1430); Unstable (1667)

Patient Problem Pain (1994)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 113633, lot: 283780 comprehensive mini stem; 118001, lot: 016610 versa-dial taper adapter; 113055, lot: 792010 comprehensive versa-dial humeral head; 113954, lot: 095580 medium biomet hybrid glenoid base; pt-113950, lot: 865440 biomet hybrid glenoid post with regenerex.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient experienced left shoulder instability two years post primary implantation.Impingement and pain were also noted at the two year follow-up visit.No revision has been reported.No further information is available at this time.

Event Description

No further information.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event 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 will be filed accordingly.Zimmer biomet will continue to monitor for trend.

• Brand Name: COMPREHENSIVE MD HYBRID GLENOID BASE 4MM
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7981718
• MDR Text Key: 124291230
• Report Number: 0001825034-2018-09078
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: PK060694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113954
• Device Lot Number: 095580
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 105