MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PALACOS BONE CEMENT

Model Number N/A

Device Problems Disassembly (1168); Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: unknown tibial component catalog # unknown lot # unknown, unknown femoral component catalog # unknown lot # unknown.Product is not returned to zimmer biomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2018- 00156, 0001822565-2018-00157.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, patient underwent a revision procedure due to pain, disassembly, and fracture.

Manufacturer Narrative

Concomitant medical products: nexgen stemmed tibial component, catalog #: 00598003701, lot #: 62964726, palacos bone cement, catalog #: 00111214001, lot #: 79884392, nexgen lps-flex femoral component, catalog #: 00596401452, lot #: 60804231, nexgen all polyethylene patella, catalog #: 00597206532, lot #: 62884640, nexgen lps-flex articular surface, catalog #: 00596203012, lot #: 62510618.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-00133, 0001822565-2018-00157, 0002648920-2018-00164.

Event Description

It was reported a patient underwent right knee revision due to pain and tibial component loosening.During the procedure, separation of tibial component and cement was noted; no other significant loosening noted.All tibial components were revised.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.After review of invoice history, patient was revised due to tibial loosening.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No devices were received; therefore the condition of the components is unknown.Insufficient information provided in order to perform dhr review for articular surface and tibial tray used.Surgical notes were not provided.Root cause cannot be determined with the information provided.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.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, it was noted that patient underwent a revision procedure due to pain and possible loosening.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown a the time of the initial medwatch.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Reported event was confirmed by review of operative notes.The revision surgical notes indicate that the patient underwent revision due to tibial loosening two years post-implantation.Intra-operatively the tibial component was found to be loose from the cement mantle, especially in the posterolateral region.No other significant loosening was noted.Dhr was reviewed and no discrepancies were found.Per the instructions for use, loosening of the prosthetic knee components is a known potential adverse effect of the tka procedure.Also, patient factors that may affect the performance of the components such as bone quality, activity level or type of activity are unknown.However, a definitive root cause cannot be determined.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: PALACOS BONE CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7185942
• MDR Text Key: 97095693
• Report Number: 0001822565-2018-00133
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: PK150119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00111214001
• Device Lot Number: 80414394
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR