MAUDE Adverse Event Report: COMP VRSDL GLNSPR 36MM TI; SHOULDER PROSTHESIS/EXTREMITIES

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02352.Medical products: item#: xl-115363, arcom xl 44-36 std hmrl brng; lot#: 756010.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the customer will not return product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a left shoulder reverse arthroplasty for an unknown reason.Subsequently, the patient began having pain during activity and was revised approximately one (1) year and eight (8) months due to pain and imagining displaying a possible fracture of implant.During the revision inflammation found with no device fracture.The glenosphere and bearing was exchanged without complications.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02352-1.Visual examination of the provided pictures identified that the glenosphere did not have any indications of a crack or fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Operative and pathology reports were reviewed.Review of the available records identified the following: initial left reverse total shoulder arthroplasty on (b)(6) 2019, subsequently revised on (b)(6) 2021 due to pain and suspected implant fracture on imaging.During the revision inflammation found with no device fracture.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.

Event Description

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

• Brand Name: COMP VRSDL GLNSPR 36MM TI
• Type of Device: SHOULDER PROSTHESIS/EXTREMITIES
• MDR Report Key: 12301179
• MDR Text Key: 265820192
• Report Number: 0001825034-2021-02351
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TI-115310
• Device Lot Number: 171290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2019
• 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: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 73