MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 12MM MICRO; PROSTHESIS, SHOULDER

Catalog Number	113612
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign- new zealand d10: cat: 110031424 lot: 6617911 standard 36mm diameter bearing unknown mini humeral tray 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
It was reported that the patient was revised approximately three months post-initial implantation due to dislocation and subsidence of the humeral stem.No additional patient consequences were reported.
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 the following section was corrected: h4 proposed annex g code: mechanical (g04) - stem d10: cat: 110031424 lot: 66179113 standard 36mm diameter bearing no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device is used for treatment.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.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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d10, g3, g6, h1, h2, h6, h11.D10: cat: 115310 lot: j7513659 comp rvrs shldr glnsp std 36mm.Visual examination of the provided picture identified the stem has biodebris on it, showing signs of implantation.The bearing and humeral tray were also explanted and are shown.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: COMP PRIMARY STEM 12MM MICRO
• 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: 19689416
• Report Number: 0001825034-2024-01789
• Device Sequence Number: 7117871
• Product Code: KWT
• UDI-Device Identifier: 00887868267628
• UDI-Public: (01)00887868267628(17)331202(10)66255313
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K060692
• 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
• Report Date (Section B): 03/25/2025

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: 113612
• Device Lot Number: 66255313
• 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: 10/01/2024; 03/10/2025
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 10/14/2024; 03/25/2025
• Date Device Manufactured: 12/02/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown