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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2023

Event Type  Injury  

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 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 Description

No further event information available at the time of this report.

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.

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 Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

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
• Type of Device: 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
• MDR Text Key: 326852609
• Report Number: 0001825034-2023-02513
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304554191
• UDI-Public: (01)00880304554191(17)260727(10)005140
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/25/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN BEARING.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male