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

Catalog Number 178711

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 07/11/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a total knee procedure.Approximately eighteen years post-implantation, the patient began to experienced pain.Diagnostic xrays revealed that the distal femoral implants were broken and disassociated.The patient underwent revision surgery to replace all femoral components distal to the compress implant.

Manufacturer Narrative

(b)(4).Concomitant medical products: oss 21cm diaphyseal segment: catalog#150473, lot#656230; oss 7cm segmental femoral lt: catalog#150355, lot#660780; cps short anchor plug 20mm: catalog#178562, lot#017960; oss mod tib baseplate 71mm: catalog#150422, lot#280450; oss poly lock pin: catalog#150478, lot#424210; oss poly femoral bushings: catalog#150477, lot#577410; oss tibial poly bearing 12mm: catalog#150410, lot#197600; cps shrt 800# large spindle ha: catalog#178580, lot#982570; oss poly tibial bushing: catalog#150476, lot#335330; oss reinforced yoke: catalog#150493, lot#569180; cps centering sleeve 21mm: catalog#178543, lot#319860; cps transverse pin 6pk 40mm: catalog#178529, lot#217100; oss axle: catalog#150480, lot#579460; cps compression cap: catalog#178399, lot#572180; cps nut co-cr-mo alloy: catalog#178512, lot#084090.Report source: foreign: canada.Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2022-01819; 0001825034-2022-01820.Customer has indicated that the product will not be returned to zimmer biomet for evaluation as the hospital has retained the product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were not provided.X-rays provided confirm the long stem left total knee arthroplasty with fracture or separation the proximal femoral component.Root cause was unable to be determined.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 Description

No further event information at time of this report.

• Brand Name: CPS/OSS 5CM TPR ADAPT W/OSS SC 5CM
• Type of Device: 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: 15202195
• MDR Text Key: 297680829
• Report Number: 0001825034-2022-01818
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K043547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

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 Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 178711
• Device Lot Number: 067500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 28 YR
• Patient Sex: Male