MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEE H11 NARRATIVE; EXTREMITY IMPLANT

Model Number	N/A
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant didn't hold up after 7 years.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial surgery for an elbow replacement approximately 7 years ago.Subsequently, the patient was revised about 2 months ago due to the bushing coming out and pain.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Updated: a2, a3, a4, b1, b3, b4, b5, b7, d2, d4 (item and lot), e1, g3, g4, h1, h2, h3, h6, h11.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
(b)(4).Updated: b4, b5, d2, g3, h1, h2, h3, h4, h6, h11.The reported event has been confirmed through the provided radiographs.Radiographs identified the following: right total elbow arthroplasty with possible loosening of the hinge pin at the joint and associated humeral component loosening distally.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d6, d9, g3, g6, h1, h2, h6, h11.The following sections were corrected: d1, d4.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
It was reported that the patient had a revision procedure approximately seven years post-initial implantation due to pain and dissociation.During the revision noted metallosis, scar tissue, implant fracture, implant wear and synovectomy of blackened tissue.The pins and bushing were exchanged without complications.The ulna and humerus remained implanted.No additional patient consequences were reported.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g3, g6, h1, h2, h4, h6, h11 the following sections were corrected: d1, d4, g4 d1: interchangeable humeral assembly for cemented use only extra small 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, h2, h3, h6.The reported event was confirmed through provided radiograph and medical records.No devices was returned or pictures provided.Device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a healthcare professional, which identified the following: pain and found to have dissociation of the components.Significant metallosis noted upon entering the joint.It was clear that the two metal fragments creating the axle for arthroplasty were moving.Bushing also broken, axle removed in separate pieces, all bushings removed findings either worn or broken.Noted significant amount of blackened metallosis tissue within and around the elbow.Ulna and humeral components were well-fixed.Review of available radiographs identified right total elbow arthroplasty with possible loosening of the hinge pin at the joint and associated humeral component loosening distally.A definitive root cause could not 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
No additional information to report at this time.

• Brand Name: SEE H11 NARRATIVE
• Common Device Name: EXTREMITY IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20427183
• Report Number: 0001822565-2024-03240
• Device Sequence Number: 12945546
• Product Code: JDC
• UDI-Device Identifier: 00889024274006
• UDI-Public: (01)00889024274006(17)220430(10)63626343
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/20/2025

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: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 32810502704
• Device Lot Number: 63626343
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 10/23/2024; 01/30/2025; 02/25/2025; 04/25/2025; 06/04/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/19/2024; 02/13/2025; 03/24/2025; 04/30/2025; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2017
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK LINER, UNK CUP, UNK STEM.
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 97 KG