MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPRESS SHORT ANCHOR PLUG 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 medical devices: oss 3cm tapered diaph segment catalog#: 151836, lot#: 514260, oss poly tibial bushing catalog#: 150476, lot#: 248780, oss reinforced yoke catalog#: 150493, lot#: 65676297, oss poly lock pin catalog#: 150478, lot#: 65676149, oss 9cm prox tib mod cocr catalog#: cp113462, lot#: 104710, oss poly femoral bushings catalog#: 150477, lot#: 65821078, cps nut co-cr-mo alloy catalog#: 178512, lot#: 65753470, oss axle catalog#: 150480, lot#: 65803980, oss 3cm resurfacing lt catalog#: 151806, lot#: 532530, oss cemented im stem 13mmx90mm catalog#: 150362, lot#: 777660, cps xs sht spdl w pins 800lbf catalog#: 178364, lot#: 636630, cps/oss 5cm tpr adapt w/oss sc catalog#: 178711, lot#: 65804239, cps transverse pin 6pk 28mm catalog#: 178526, lot#: 173300, cps transverse pin 6pk 24mm catalog#: 178525, lot#: 501720, oss tibial poly bearing 18mm catalog#: 150413, lot#: 622640.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent a left knee revision approximately sixteen (16) months post-implantation due to fracture of the anchor plug.No additional patient consequences were reported.
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.The following sections were updated/corrected.Updated: b4, b5, g3, g6, h1, h2, h3, h6, h11.Visual examination of the returned product identified damage in the form of nicks and gouges.The shaft of the implant is fractured with the end of the post not returned.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The implant was submitted for further analysis.Analysis determined fatigue striation on the fractured surface suggest a fatigue failure mode.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional and it was determined further review would not enhance the investigation.Complaint is confirmed with product return.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: COMPRESS SHORT ANCHOR PLUG 10MM
• Common Device Name: PROSTHESIS, KNEE
• 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: 19960275
• Report Number: 0001825034-2024-01989
• Device Sequence Number: 15220015
• Product Code: KRO
• UDI-Device Identifier: 00880304461659
• UDI-Public: (01)00880304461659(17)321020(10)860830
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K062998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178552
• Device Lot Number: 860830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 67 KG