MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL GLENOID COMPONENT 46 MM ARTICULAR SURFACE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094)

Event Date 11/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs.Product id: 113610, comp primary stem ,10mm micro, lot#: 115800, mdr: 0001825034-2022-02745.Item#118001; lot# 139970 product id: 113032, versa-dial, 42x18x46 hum head, lot#: 214780, mdr: 0001825034-2022-02748.Additional associated products: product id: 118001, versa-dial/comp ti std taper.

Event Description

It was reported that a patient is scheduled for a revision surgery six(6) years post implantation due disassociation and pain.Attempts have been made and no further information has been provided at this time.

Event Description

It was reported a patient underwent the stage i of a two stage revision due to a large, non-contained, glenoid defect approximately 7 years post implantation.During the surgery, the glenoid was found fragmenting and a synovectomy was performed due to synovitis.All components were removed and a spacer was placed.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  no product was returned; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing the reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this or the reported part and lot combination.X-ray images were sent to mmi for review, with the following noted: five views of the left shoulder demonstrate a left total shoulder arthroplasty with fractured glenoid component along the superior aspect.Significant radiolucency along the superior glenoid is present.Multiple linear and globular hyperdense foci along the joint capsule suggests synovitis or metallosis.Medical records were received and the following was noted: synovitis with synovectomy.Failed left total shoulder arthroplasty performed at an outside facility, with fragmenting glenoid, with large uncontained posterior glenoid defect.- removed the glenoid; however, there was no backside, so all this was just preserving the front side.Eventually wiggled it out, and there was a large non-contained defect.- defect in the glenoid was so large, performing it in a single stage would be impossible.The complaint is confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: TRABECULAR METAL GLENOID COMPONENT 46 MM ARTICULAR SURFACE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16022491
• MDR Text Key: 305886414
• Report Number: 0001822565-2022-03533
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

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 Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00432604046
• Device Lot Number: 62700439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2014
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female