MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS/OSS 5CM TPR ADAPT W/OSS SC; PROSTHESIS, KNEE

Catalog Number	178711
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial surgery on an unknown date.Subsequently, the patient was revised due to the compress segment taper separating.It was noted that the technique says screws are optional.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: 150467 - oss 9cm diaphyseal segment - 66753175.178366 - cps sm sht spdl - 66286084.178512 - cps nut co-cr-mo alloy - 66459361.178549 - tpr adpt female oss/female - 931510.178548 - taper adpt female oss/male - 66386242.178531 - cps transverse pin 6pk - 998570.178529 - cps transverse pin 6pk - 173460.178556 - cps short anchor plug - 199300.150364 - oss cemented im stem - 099860.178539 - cps centering sleeve - 569790.The 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h11 the reported event could not be confirmed.Visual examination of the returned product (item 178711) identified signs of use (gouges).Dimensional analysis of the product determined that the product, where measured, was conforming to its print specifications.Visual examination of the returned product (item 150467) identified signs of use (gouges) on exterior of device & striations on inside of the taper bore.Dimensional analysis of the product determined that the product, where measured, was conforming to its print specifications.Medical records were not provided.The reported products were reviewed for compatibility with no issues noted.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as use error.The oss orthopedic salvage system compress device surgical technique outlines which components are required, and which are optional.The oss diaphyseal stacking adapter was not used between the oss / compress taper adapter (5 cm) and the oss diaphyseal segment (5 cm).This would contribute to the reported event of the compress segment taper separating.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: CPS/OSS 5CM TPR ADAPT W/OSS SC
• 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: 22183562
• Report Number: 0001825034-2025-01686
• Device Sequence Number: 8690469
• Product Code: KWA
• UDI-Device Identifier: 00880304430792
• UDI-Public: (01)00880304430792(17)340913(10)66883147
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K043547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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 Catalogue Number: 178711
• Device Lot Number: 66883147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female