MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD STEM - 6X100MM; PROSTHESIS, SHOULDER, NON CONSTRAINED, METAL/POLYER CEMENTED/EXTREMITIES

Catalog Number	211235
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).H6: component codes: mechanical (g04) - stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided for the loosening event and reviewed by a health care professional.Review of the available records identified the following: overall alignment at the elbow articulation is maintained.There is marked malalignment with proximal implant migration after the distal humeral fracture.After the fracture, the humeral implant is loose and subsided.Bone quality has significantly progressed from mild osteopenia on the initial image to advanced osteopenia on the later image.After the humeral fracture the humeral implant was loose and proximally migrated as noted with stem extension through the humeral head.This could be secondary to trauma, with increased risk of fracture due to the advanced osteopenia.No component malfunction is identified.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 or Problem Description
It was reported that the patient underwent an initial surgery approximately four (4) years and two (2) months ago.Subsequently, the patient underwent a revision surgery on an unknown date due to the implant loosening.

• Brand Name: COMPR SRS MOD STEM - 6X100MM
• Common Device Name: PROSTHESIS, SHOULDER, NON CONSTRAINED, METAL/POLYER CEMENTED/EXTREMITIES
• 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: 20569892
• Report Number: 0001825034-2024-02555
• Device Sequence Number: 7532265
• Product Code: KWT
• UDI-Device Identifier: 00880304540378
• UDI-Public: (01)00880304540378(17)300303(10)533370
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K223631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 211235
• Device Lot Number: 533370
• 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: 10/23/2023
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 113 KG