MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS CENTERING SLEEVE 14MM; PROSTHESIS, KNEE

Catalog Number 178536

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical product: cps nut co-cr-mo alloy: catalog#178512, lot#278090; cps short anchor plug 12mm: catalog#178554, lot#201400; cps sm sht spdl w pins 600lbf: catalog#178366, lot#201280; cps/oss 5cm tpr adapt w/oss sc: catalog#178711, lot#65832852; oss poly lock pin: catalog#150478, lot#65676151; oss reinforced yoke: catalog#150493, lot#65676301; oss poly tibial bushing: catalog#150476, lot#65758797; oss tibial poly bearing 12mm: catalog#150410, lot#434030; oss segmental stacking adapter: catalog#150483, lot#861550, qty#2; cps transverse pin 6pk 28mm: catalog#178526, lot#197640; oss non-mod tib plate short 67: catalog#150417, lot#65676027; oss 3cm diaphysel segment: catalog#150464, lot#65766550; oss 3cm diaphysel segment: catalog#150464, lot#65832502; oss rs 7 cm mod seg fmrl-rt: catalog#161011, lot#65677296; oss rs poly fem bushings set/2: catalog#161034, lot#507810; oss rs axle: catalog#161035, lot#65850072.Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2024-00053; 0001825034-2024-00054; 0001825034-2024-00056.The product has been received by zimmer biomet and the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right orthopedic salvage prosthesis implantation on an unknown date.Subsequently, the patient underwent revision surgery due to disengagement of the compression nut.The affected components were revised without reported complication.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: a1; a2; a3; b4; b5; g3; h2; h10.The following sections have been corrected: b3; d6a,b; d10 the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a right orthopedic salvage prosthesis implantation.Subsequently, seven (7) months post-implantation, the patient underwent revision surgery due to disengagement of the compression nut.The affected components were revised without reported complication.All available information has been reported.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h4; h6; h11.Visual examination of the returned product found that the nut showed no signs of damage but the anchor plug had damaged threads.The sleeve and spindle were still assembled.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: compression nut disengagement/implant failure presumably indicated by change in position of the spindle with respect to the femoral component.Correlate clinically.Root cause was unable to be determined.Reported event was confirmed by review of returned device and provided medical records.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.

• Brand Name: CPS CENTERING SLEEVE 14MM
• 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: 18457440
• MDR Text Key: 332261120
• Report Number: 0001825034-2024-00055
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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 Catalogue Number: 178536
• Device Lot Number: 65753484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male