MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 18MM MICRO; EXTREMITY IMPLANT

Model Number	N/A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: australia.H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02514.H3 other text : unknown.
Event or Problem Description
It was reported a patient underwent a shoulder arthroplasty approximately 2 weeks ago.Subsequently, the patient was revised due to incorrect alignment of implants.The baseplate was left in, but there was a size exchange of the other components.Attempts have been made and there is no further information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).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.H3 other text : discarded.
Additional Manufacturer Narrative
(b)(4).H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, d2, g3, h1, h2, h3, h6, h10 mechanical (g04) - stem reported event was unable to be confirmed due to limited information received from the customer and x-rays are not dated.Radiographs identified the following: not submitted to mmi as the image is not dated.This is an early post-op x-ray given the presence of incisional staples, however it is not clear whether this was pre or post revision as the initial surgery had only occurred one day prior.Therefore it would be difficult to correlate to the allegation and would not enhance the investigation.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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 PRIMARY STEM 18MM MICRO
• Common Device Name: EXTREMITY IMPLANT
• 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: 18029635
• Report Number: 0001825034-2023-02513
• Device Sequence Number: 5672068
• Product Code: HSD
• UDI-Device Identifier: 00880304554191
• UDI-Public: (01)00880304554191(17)260727(10)005140
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060692
• 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,Followup,Followup
• Report Date (Section B): 01/25/2024
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 07/27/2026
• Device Model Number: N/A
• Device Catalogue Number: 113618
• Device Lot Number: 005140
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 11/02/2023; 11/30/2023; 01/19/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/29/2023; 12/21/2023; 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BEARING.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male