MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STANDARD 36MM DIAMETER BEARING; PROSTHESIS, SHOULDER

Catalog Number	110031424
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised approximately three months post-initial implantation due to dislocation.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).G2: foreign- new zealand.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d4, g3, g6, h1, h2, h4, h11 corrected section: d4( lot number).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
No additional event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
D10: 113612 66255313 comp primary stem 12mm micro.Reported event was confirmed by review of radiographs.Review of the available records identified the following: initial implant fit and alignment were normal with subsequent dislocation.No implant loosening.Bone quality is unremarkable.Subsequently, there is malalignment due to dislocation.No other abnormalities.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device is used for treatment.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g3, g6, h1, h2, h3, h6, h11.Reported event was confirmed by review of radiographs and pictures.Visual examination of the provided picture identified the bearing has biodebris on it, showing signs of implantation.There is no evidence of abnormal wear with what is visible of the device.Root cause was unable to 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 is available at the time of this report.

• Brand Name: STANDARD 36MM DIAMETER BEARING
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19700277
• Report Number: 0001822565-2024-02286
• Device Sequence Number: 7776626
• Product Code: KWS
• UDI-Device Identifier: 00887868231551
• UDI-Public: (01)00887868231551(17)281118(10)66179113
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K181611
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/28/2025

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: 110031424
• Device Lot Number: 66179113
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 12/19/2024; 03/21/2025
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/26/2024; 12/31/2024; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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: UNKNOWN MINI HUMERAL TRAY
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown