MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X20 ST; SHOULDER PROSTHESIS SCREW

Catalog Number 180551

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

Patient Problems Erosion (1750); Pain (1994); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Phx.Comp primary stem 12mm mini m mini cat# 113632 lot# 804550, comp rvrs shldr glnsp std 36mm cat# 115310 lot# 197430, comp aug mini bsplt w tpr md cat# 110032420 lot# 64175596, comp rvs cntrl 6.5x35mm st/rst cat# 115397 lot# 168370, comp lk scr 3.5hex 4.75x15 st cat# 180550 lot# 563970, comp lk scr 3.5hex 4.75x15 st cat# 180550 lot# 563970, comp lk scr 3.5hex 4.75x20 st cat# 180551 lot# 276830.Mini humeral tray standard thickness +3 mm taper offset 40 mm diameter cat# 110031402 lot# 64282536.Bearing standard 36 mm diameter cat# 110031418 lot# 64361162.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: 0001825034-2020-03553, 0001825034-2020-03554, 0001825034-2020-03555, 0001825034-2020-03556, 0001825034-2020-03557, 0001825034-2020-03558, 0001825034-2020-03560.

Event Description

It was reported that a patient underwent an initial left total shoulder arthroplasty.Subsequently, it was noted at one year follow-up, a grade one notching of the glenoid, severe pain, limited range of motion, instability, and decrease in activity of daily living.No revision procedure has been reported to date.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.D4: udi: (b)(4).Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: at 6-week follow up: x-rays ¿ benign, rom 60, 30, 30, severe pain 7.5, ases score 12.5, health score 60.At 6-month follow up: x-rays ¿ benign, rom 60, 30, 30, severe pain 5.5, ases score 24.2, health score 35.At 1-year follow up: x-rays - grade 1 notching of the glenoid component, rom 15, 0, instability 7.6, severe pain 8.5, unable to do usual adl¿s, ases score 9.2, health score 65.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.

• Brand Name: COMP LK SCR 3.5HEX 4.75X20 ST
• Type of Device: SHOULDER PROSTHESIS SCREW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10547250
• MDR Text Key: 207370162
• Report Number: 0001825034-2020-03559
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K132239
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 180551
• Device Lot Number: 276830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 68