MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL REVERSE HUMERAL STEM SPACER 12MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Information (3190)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional report submitted for this event: mfr# 0001822565-2018-00148.Additional concomitant medical products: trabecular metal reverse poly liner 36mm plus 6mm offset, pn00434903606, ln62429272.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the revision procedure has not yet taken place.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient has been indicated for a second left shoulder revision approximately 3.5 years post-implantation due to instability.No revision procedure has been reported to date.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Post revision x-ray review shows that the glenoid component appears to be horizontally positioned which may or may not contribute to the patient's instability given the high activity level of the patient.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.X-ray review states: left shoulder reverse arthroplasty without hardware failure or loosening.Small ossific density noted posterior to the joint space on the scapular y film.No fracture identified.No radiolucency.Cementing technique is poorly evaluated as no significant cement is identified along the humeral component.Patient's activity may contribute to the condition of instability.Glenoid component appears to be horizontally positioned which may or may not contribute to the patient's instability given their activity.Dhr was reviewed and no discrepancies were found.Review of complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported a patient underwent a second left shoulder revision approximately 3.5 years post-implantation due to instability.Humeral stem spacer and poly liner were replaced with a custom device.

• Brand Name: TRABECULAR METAL REVERSE HUMERAL STEM SPACER 12MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7218955
• MDR Text Key: 98225233
• Report Number: 0001822565-2018-00147
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2018

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: Physician
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 00434903912
• Device Lot Number: 62278467
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 03/15/2018; 03/30/2018
• Supplement Dates FDA Received: 03/16/2018; 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2013
• 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