MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD STEM - 8X100MM; COMPREHENSIVE SRS MODULAR STEM WITH SCREW

Catalog Number 211236

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Date 01/24/2024

Event Type  Injury  

Event Description

It was reported that the patient had a complex revision history of a right reverse total shoulder arthroplasty including multiple periprosthetic fracture repairs and mrsa infection in the joint.The patient underwent a revision approximately four (4) years and nine (9) months after the previous revision due to loosening of the srs implant over time.Furthermore, the surgeon requested a custom intercalary segment to be made to allow for previous segments to remain and attach the custom which would allow for a standard line distal humeral component to complete a total humeral construct.Since revision, the patient is doing well with pain and swelling has resolved.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: item# 211215; lot# 179160 item# 211226; lot# 966890 item# 211229; lot# 739710 item# 115340; lot# 738490 item# 118000; lot# 139820 item# xl-115368; lot# 469610 item# ti-115323; lot# 620400 customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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.

• Brand Name: COMPR SRS MOD STEM - 8X100MM
• Type of Device: COMPREHENSIVE SRS MODULAR STEM WITH SCREW
• 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: 18944788
• MDR Text Key: 338186871
• Report Number: 0001825034-2024-00726
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 00880304540484
• UDI-Public: (01)00880304540484(17)290204(10)829710
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211236
• Device Lot Number: 829710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female