MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD W/VARIABLE; EXTREMITIES IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Impingement (4834)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A1 - 1944.D10 - medical product: catalog #: 115736, compr nano hmrl pps 36mm, lot # 945850; catalog #: 118001, versa-dial/comp ti std tape, lot # 985080; catalog #: 113954, md hybrid glenoid base 4mm, lot # 494700; catalog #: pt-113950, pt hybrid glen post regenerex, lot # 279250.G2: uk.H3: 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: 0001825034-2023-02213, 0001825034-2023-02214, 0001825034-2023-02216, 0001825034-2023-02217.
Event or Problem Description
It was reported that an initial right total shoulder arthroplasty was implanted approximately 8 years ago.Three years later the patient reported severe pain, decreased range of motion, impingement and was prescribed narcotics.A few weeks ago, it was reported that the patient was experiencing unusual shoulder pain and the patient was referred to pain management clinic on an unknown date.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Mechanical (g04) - head.The reported event of pain is confirmed via joint/prothesis review per mmi.Impingement and range of motion could not be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and identified the following: anterosuperior subluxation of the right shoulder arthroplasty.Osteopenia.Acromioclavicular joint arthrosis.Other than the arthroplasty subluxation, which could result in pain, no other implant concerns are identified.There is advanced right acromioclavicular joint arthrosis which could also result in pain.Device history record was reviewed and no discrepancies relevant to the reported event were found.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 SHOULDER SYSTEM MODULAR HEAD W/VARIABLE
• Common Device Name: EXTREMITIES IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17818707
• Report Number: 0001825034-2023-02215
• Device Sequence Number: 16764271
• Product Code: HSD
• UDI-Device Identifier: 00880304212220
• UDI-Public: (01)00880304212220(17)240331(10)238100
• 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: 2015
• 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
• Report Date (Section B): 02/28/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 113042
• Device Lot Number: 238100
• Was Device Available for Evaluation?: No
• 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: 09/01/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 95 KG