MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 42X24X42 HUM HEAD; PROSTHESIS, SHOULDER

Catalog Number	113036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to rotator cuff failure.All implants were removed and replaced with a reverse shoulder system.No further information is available.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The reported event has been made not reportable.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The reported event has been made not reportable.

• Brand Name: VERSA-DIAL 42X24X42 HUM HEAD
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 18881967
• Report Number: 0001825034-2024-00689
• Device Sequence Number: 7838769
• Product Code: KWS
• UDI-Device Identifier: 00880304460812
• UDI-Public: (01)00880304460812(17)280612(10)998610
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K040610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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 Catalogue Number: 113036
• Device Lot Number: 998610
• 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: 02/11/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2018
• 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: Unknown