MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL POLY LINER PLUS 3 MM; PROSTHESIS, SHOULDER

Catalog Number 00434903603

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Osteopenia/ Osteoporosis (2651); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00434901413 humeral stem 14 mm 6248547, 00434903611 glenosphere 36 mm diameter 62540042, 00434901500 base plate 15 mm post 62541526.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 03681, 0001822565 - 2019 - 03683, 0001822565 - 2019 - 03684.

Event Description

It was reported through the clinical study that the patient had an initial right reverse total shoulder replacement.Subsequently, the patient complained of dissatisfaction and pain due to acromion fracture six (6) months post primary implantation after an unknown incident in therapy and the patient was treated to full recovery.No additional patient harm has been reported.

Manufacturer Narrative

Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Review of provided ct scan identified chronic ununited fracture of the acromion process with inferiorly displace fracture fragment narrowing the subacromial space.Fracture of acromion of scapula, right, sequela.A definitive root cause cannot 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 trends.

Event Description

No additional event information is available at the time of this report.

• Brand Name: TRABECULAR METAL POLY LINER PLUS 3 MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8956777
• MDR Text Key: 156386032
• Report Number: 0001822565-2019-03682
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

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: 09/30/2021
• Device Catalogue Number: 00434903603
• Device Lot Number: 62471628
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 09/17/2019
• 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: 73 YR
• Patient Weight: 78