MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 46X18X53 HUM HEAD; SHOULDER, PROSTHESIS

Model Number	113042
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign: (b)(6).Concomitant medical devices: versa-dial 42x18x46 hum head cat: 113032 lot: 769270; comp primary stem 9mm mini cat: 113629 lot: 131150; versa-dial/comp ti std taper cat: 118001 lot: 187910; versa-dial/comp ti std taper cat: 118001 lot: 187910.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.
Event or Problem Description
It was reported that the patient was revised due to wear and dislocation of the implant.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that the patient was revised due to wear and dislocation of the implant.During the procedure, the screw heads were noted to be totally worn this caused the baseplate to be loose.Metallosis was noted to be present.The poly was disassociated and the head was dented.A bone graft was needed to complete the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b3, b4, b5, d6, g3, g7, h1, h2, h10 the following section was corrected: g2 g2: foreign - spain 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: evidence of interval liner wear and superior subluxation of the humeral implant in relation to the glenoid implant.There is no fracture or evidence of implant loosening.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.
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.Proposed annex g code: mechanical (g04) - head.Visual examination of the returned product identified scratches and wear marks.The results of the original investigation have not changed, 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: VERSA-DIAL 46X18X53 HUM HEAD
• Common Device Name: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12843353
• Report Number: 0001825034-2021-03165
• Device Sequence Number: 4205409
• Product Code: HSD
• UDI-Device Identifier: 00880304212220
• UDI-Public: (01)00880304212220(17)290401(10)043520
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/08/2022

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 Model Number: 113042
• Device Catalogue Number: 113042
• Device Lot Number: 043520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 11/22/2021; 03/17/2022; 11/07/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/21/2021; 03/23/2022; 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male