MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS 5CM TAPERED DIAPH SEGMENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10-medical product cps sm sht spdl w pins 600lbf item# 178366 lot# 567750.Cps short anchor plug 12mm item# 178554 lot# 064040.Cps transverse pin 6pk 32mm item# 178527 lot# 197690.Cps nut co-cr-mo alloy item# 178512 lot# 967810.Cps centering sleeve 15mm item# 178537 lot# 716810.Cps taper locking cap / oss sc item# 178710 lot# 779270.Oss poly bumper lock pin item# 150510 lot# 695180.Oss poly lock pin item# 150478 lot# 747330.Oss 9cm tapered diaph segment item# 151840 lot# 018020.Oss rs axle item# 161035 lot# 394270.Oss rs poly fem bushings set/2 item# 161034 lot# 507840.Cps/oss 5cm tpr adapt w/oss sc item# 178711 lot# 708850.Oss poly tibial bushing item# 150476 lot# 690760.Oss reinforced yoke item# 150493 lot# 510100.Oss segmental stacking adapter item# 150483 lot# 600600.Oss rs 12mm ls tibial bearing item# 161094 lot# 270810.Oss rs 7 cm mod seg fmrl-rt item# 161011 lot# 031310.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.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 a patient will need a revision due to compress failure.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional, and it was determined further review would not enhance the investigation.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.The complaint is not confirmed.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch 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.

• Brand Name: OSS 5CM TAPERED DIAPH SEGMENT
• 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: 20085023
• Report Number: 0001825034-2024-02098
• Device Sequence Number: 7655154
• Product Code: JDI
• UDI-Device Identifier: 00880304674905
• UDI-Public: (01)00880304674905(17)310225(10)131140
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K141331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/04/2025

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: 151838
• Device Lot Number: 131140
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2021
• 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: Other
• Patient Sex: Unknown