MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COMPREHENSIVE GLENOID; PROSTHESIS, SHOULDER

Catalog Number UNKNOWN COMPREHENSIVE GLENOID

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

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

It was reported that a journal article was retrieved from seminars in arthroplasty: jses (2021), involving a retrospective study conducted in the united states.The purpose of the study was to compare the clinical subscapularis failure rates between transosseous repair (tor) and direct primary tendon repair (ptr) in patients who had anatomic total shoulder arthroplasty (tsa).The study reported 7 patients experienced postop medical complications of dvt/pe.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02023.0001825034-2022-02024.Item# unknown comprehensive humeral head; lot# unknown.Item# unknown comprehensive stem; lot# unknown.Full establishment name - (b)(6) clinic.Literature - article title - failure rates and outcomes after anatomic total shoulder arthroplasty are equivalent irrespective of subscapularis repair technique.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.It was reported by a study that seven patients experienced post-operative complication of either a deep vein thrombus or a pulmonary embolism, within an unknown timeframe.  procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.  a post-operative complication developed and it can be implied medical intervention was required to treat the complication.  the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.If any further information which would change or alter any conclusions or information, a supplemental report 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: UNKNOWN COMPREHENSIVE GLENOID
• Type of Device: 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: 15336124
• MDR Text Key: 299069718
• Report Number: 0001825034-2022-02025
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN COMPREHENSIVE GLENOID
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose