MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS 3CM RESURFACING LT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient who underwent oss operation.Patient felt a pain around the patella tendon and went to see a doctor approximately 3 years post implantation.The diagnoses confirmed the screw which had connected the femoral component and the stem backed out.The patient was revised about 2 weeks post diagnosis to remove/replace the screw.Only the screw was replaced.The femoral implant remained intact.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 150446 oss cmntd prox tib stem 13x150, lot #: 343890; 178711 cps/oss 5cm tpr adapt w/oss sc lot #: 419210; 178554 cps short anchor plug 12mm lot #: 037950; 178538 cps centering sleeve 16mm lot #: 453160; 178526 cps transverse pin 6pk 28mm, lot #: 995740; 178512 cps nut co-cr-mo alloy, lot #: 484670; 178367 cps sm sht spdl w pins 800lbf, lot #: 638390; 150493 oss reinforced yoke, lot #: 741550; 150480 oss axle, lot #: 113170; 150478 oss poly lock pin, lot #: 562280.
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, d2, g1, g3, g6, h1, h2, h3, h6, h10.  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.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: backing out of a screw at the distal femoral implant that extends to the region of the inferior patellar tendon.This complaint has been confirmed by the returned x-ray images showing a screw that has been backed out.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 3CM RESURFACING LT
• 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: 16459745
• Report Number: 0001825034-2023-00416
• Device Sequence Number: 6515155
• Product Code: JDI
• UDI-Device Identifier: 00880304674301
• UDI-Public: (01)00880304674301(17)251208(10)754980
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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 Expiration Date: 12/08/2025
• Device Model Number: N/A
• Device Catalogue Number: 151806
• Device Lot Number: 754980
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 74 KG