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

Catalog Number 113633

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

Patient Problems Ossification (1428); Hematoma (1884)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: mini humeral tray +5 mm thickness +0 mm taper offset 40 mm diameter cat 110031400 lot# 64336369.Bearing +3 mm thickness 40 mm diameter cat# 110031422 lot# 64291297.Glenosphere standard offset 40 mm diameter cat# 110030776 lot# 11024225.Comp aug mini bsplt w tpr md cat# 110032420 lot# 64155088.Comp rvs cntrl 6.5x25mm st/rst cat# 115395 lot# 840070.Comp lk scr 3.5hex 4.75x15 st cat# 180550 lot# 462580.Comp lk scr 3.5hex 4.75x15 st cat# 180550 lot# 206550.Comp lk scr 3.5hex 4.75x30 st cat# 180553 lot# 750870.Comp lk scr 3.5hex 4.75x30 st cat# 180553 lot# 028290.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -00079, 0001825034 -2020 -00080, 0001825034 -2020 -00081, 0001825034 -2020 -00082, 0001825034 -2020 -00083, 0001825034 -2020 -00084.

Event Description

It was reported the patient underwent a primary right total shoulder arthroplasty.Subsequently, the patient was noted to have an aspiration of a hematoma approximately 45 days later.The patient was also noted to have heterotopic ossification at the 6-month follow-up; however, no intervention was noted at this time and the patient continues to have improved outcome measures.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: primary op notes and preop notes were reviewed and no complications were noted.Crf medical notes were reviewed and identified the following.6 week visit : reviewed record without any significant findings.Ases: rom & adl¿s improving, stability increasing.Improvement without overall eq-5d.Ap and axillary radiographs taken without significant findings.Adverse event days after: right shoulder hematoma aspirated and noted to be resolved.6 month visit: ap and axillary radiographs taken with finding of heterotopic ossification at the inferior glenoid zones 1-3.Ases: rom, adls and stability improved from pre-operative findings.Eq-5d: improvement from pre-operative excluding mobility which now notes moderate problems.Review of the device history records identified no (related) deviations or anomalies during manufacturing.The root cause for the reported issues are related to the procedure and are not abnormal to the procedure.No failure detected with the devices.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: COMPREHENSIVE MINI PRIMARY STEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9552532
• MDR Text Key: 173970069
• Report Number: 0001825034-2020-00078
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K060692
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 113633
• Device Lot Number: 996880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 91