MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 14MM STD; PROSTHESIS, SHOULDER

Catalog Number 113654

Device Problem Fracture (1260)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cr prolong 40mm brng std cat# 110031421 lot# 64343820.Cr 40mm glenosphere +3mm cocr cat# 110030777 lot# 64316101.Mini tray +5mm cocr +0 offset cat# 110031400 lot# 64474721.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.

Event Description

It was reported post revision to left shoulder, the patient experienced pain.A ct scan was performed and it was found that there was an abnormality of taper which appears as a small portion of metal that is fractured from the stem itself.Patient continues to experience limited function and pain to left shoulder.Further, the product currently remains implanted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h2, h3, h6, h10.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial procedure completed without complications.Ct scan- report no significant findings, muscle volume loss.Followup findings: constant ache 6-7/10, denies numbness/tingling to shoulder or hand.X-ray and ct scan indicate no abnormal findings, well seated/placed implant.Ct scan images reviewed by surgeon, provided to zimmer biomet to review as well.Abnormality of taper, appears there is a small portion of metal that is fractured from the stem itself.Doesn¿t appear disengaged, recommended to the patient exploratory procedure.Painful reverse total shoulder w/ likely 1-2 mm fracture/disassociation at taper, appears stable.Met with patient and zb rep, recommend that appears stable to monitor as patient was not ready for major revision procedure.Persistent pain, limiting left upper extremity activities.Scheduled for biopsy.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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 further event information is available at the time of this report.

• Brand Name: COMP PRIMARY STEM 14MM STD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10253584
• MDR Text Key: 198321334
• Report Number: 0001825034-2020-02701
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2019
• Device Catalogue Number: 113654
• Device Lot Number: 007880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 76