MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 42X18X46 HUM HEAD; PROSTHESIS, SHOULDER

Model Number	113032
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 115738, 648840, compr nano hmrl pps 38mm 118001, 775140, versa-dial/comp ti std taper 113954, 720760, md hybrid glenoid base 4mm pt-113950, 162240, pt hybrid glen post regenerex unknown unknown palacos cement.Report source foreign: (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 - 01498 0001825034 - 2021 - 01500 0001825034 - 2021 - 01501.
Event or Problem 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 or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 42X18X46 HUM HEAD
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11835670
• Report Number: 0001825034-2021-01499
• Device Sequence Number: 4229817
• Product Code: HSD
• UDI-Device Identifier: 00880304212206
• UDI-Public: (01)00880304212206(17)260215(10)038270
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2026
• Device Model Number: 113032
• Device Catalogue Number: 113032
• Device Lot Number: 038270
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Weight: 111