MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL/COMP TI STD TAPER; PROSTHESIS, SHOULDER

Model Number 118001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 115738, 648840, compr nano hmrl pps 38mm.113032, 038270, versa-dial 42x18x46 hum head.113954, 720760, md hybrid glenoid base 4mm.Pt-113950, 162240, pt hybrid glen post regenerex.Unknown unknown palacos cement.Report source:(b)(6).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: 0001825034 - 2021 - 01497, 0001825034 - 2021 - 01499, 0001825034 - 2021 - 01500, 0001825034 - 2021 - 01501.

Event Description

It was reported that an initial left total shoulder arthroplasty was performed.At the 5-year visit, the patient reported moderate pain, instability, impingement, and loss of range of motion.Glenoid component migration was noted on the x-ray.The patient has been referred for an orthopedic consult but has not yet had any intervention.The outcome is pending.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b6, g3, g6, h2, h3, h6, h10.The device history records were reviewed and no discrepancies were identified.Medical records were received and reviewed.The patient's post-operative visits reported pain and instability.The patient's most recent x-rays showed possible loosening of the glenoid component with inferior migration over a five-year period.The humeral component was intact.A definitive root cause could not be determined with the information 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.

• Brand Name: VERSA-DIAL/COMP TI STD TAPER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11835633
• MDR Text Key: 252705401
• Report Number: 0001825034-2021-01498
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304217249
• UDI-Public: (01)00880304217249(17)260118(10)775140
• Combination Product (y/n): N
• PMA/PMN Number: K193038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

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 Model Number: 118001
• Device Catalogue Number: 118001
• Device Lot Number: 775140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 05/17/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 111