MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE VRS MINI TAPER ADAPTOR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110031378
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a few days following an initial arthroscopy procedure, the patient experienced implant dissociation.The patient underwent additional surgery approximately one (1) week following the original procedure, and the surgeon discovered that the central screw wasn't fully tightened, causing the looseness.The screw was adjusted, and other concomitant devices were retained during the revision, with no other patient harm reported.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products, part number (lot number): 115396 (unknown), 110027734 (66500759).Associated product information: 113633 (64964350), 180554 (unknown), 180554 (unknown), 180555 (unknown), 180555 (unknown), 180556 (unknown), 405800 (66394301), 110010066 (66500764), 110030777 (66072611), 110031400 (66394125), 110031429 (65434183).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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
Corrections to d6b and d9; this product was explanted during the revision and returned for evaluation.The reported event is confirmed as the returned taper adaptor shows scuffs consistent with disassociation between the taper adaptor and the baseplate.Visual examination of the returned product/provided pictures identified the devices returned showed wear with the bearing being worn and the taper adaptor having scuff marks.The glenosphere has light scratches on the od.Measured the overall height and outer diameter of the glenosphere and both were conforming.A review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.As it is unknown when the screw became unseated, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMPREHENSIVE VRS MINI TAPER ADAPTOR
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 19209312
• Report Number: 0001825034-2024-01097
• Device Sequence Number: 15435582
• Product Code: PHX
• UDI-Device Identifier: 00880304834026
• UDI-Public: (01)00880304834026(17)331221(10)66500762
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K202232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/29/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110031378
• Device Lot Number: 66500762
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: H11
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Male