MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVSR SHLDR GLNSP +3 36MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	115313
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an initial shoulder arthroplasty due to a three (3) month old four (4) part proximal humerus fracture.Subsequently, the patient was revised approximately one (1) month later due to the implants dislocating multiple times in an anterior position.During the revision the surgeon removed a large piece of bone from the original fracture due to the surgeon believing that the piece of bone was contributing to the reason that the implants were dislocating.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 110031400, mini +5mm thickness +0mm taper offset 40mm diameter humeral tray; lot#: 65337911 item#: 110031424, standard 36mm diameter bearing; lot#: 65761059 g2: foreign: australia h3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested from the hospital but not returned to the customer.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Component codes: mechanical (g04) - head.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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.

• Brand Name: COMP RVSR SHLDR GLNSP +3 36MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• 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: 17948876
• Report Number: 0001825034-2023-02406
• Device Sequence Number: 7820723
• Product Code: PHX
• UDI-Device Identifier: 00880304475779
• UDI-Public: (01)00880304475779(17)310714(10)745830
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 12/21/2023

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: 115313
• Device Lot Number: 745830
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown