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

Catalog Number	211236
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteopenia/ Osteoporosis (2651); Radiolucent Lines (4848)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.(b)(4).H6: proposed annex g code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: original srs loosened over time and required revision surgery on (b)(6) 2024.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 50mm humeral component to complete a total humeral construct.Possible loosening of the distal humeral component on pre-revision images.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.

• Brand Name: COMPR SRS MOD STEM - 8X100MM
• Common Device Name: 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
• Report Number: 0001825034-2024-00726
• Device Sequence Number: 8232205
• Product Code: KWT
• UDI-Device Identifier: 00880304540484
• UDI-Public: (01)00880304540484(17)290204(10)829710
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K223631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2019
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female