MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS POLY BUMPER LOCK PIN; PROSTHESIS, KNEE

Catalog Number	150510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient was revised to to the bumper locking pin fracture/sheered off.The patient was revised successfully.
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmerbiomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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, d5, g3, g6, h1, h2, h3, h4, h6, h11.Visual examination of the returned product identified signs of implantation in the form of nicks and gouges, as well as the post feature being fractured from the rest of the implant.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The was submitted for further analysis.Analysis determined the base of the locking pin and the bumper fragment both show possible evidence of stress whitening and slight plastic deformation at the fracture surface.The superior side of the bumper show possible evidence of impingement damage, possible from the femoral implant during hyperextension.The tabs on the inferior side of the bumper both appear to be completely worn away, and both sides of the bumper show extensive abrasions, wear, and/or pitting.The failure of the bumper locking pin was due to the high bending or shear forces on the pin after insertion, possibly exacerbated by the impingement from the femoral implant.The tab may have separated from the locking pin some time before explantation, resulting in the extensive wear or abrasions covering both sides of the bumper.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.The event is confirmed.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: OSS POLY BUMPER LOCK PIN
• 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: 22005300
• Report Number: 0001825034-2025-01380
• Device Sequence Number: 15731812
• Product Code: KRO
• UDI-Device Identifier: 00880304677173
• UDI-Public: (01)00880304677173(17)250924(10)952830
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K051479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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
• Device Expiration Date: 09/24/2025
• Device Catalogue Number: 150510
• Device Lot Number: 952830
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown