MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 1; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 06/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: articular surface size 1 10 mm height femoral size a,b,c,d,e,f,g, catalog#: 00584202110, lot#: 62686349; femoral component high flex precoat for cemented use only right medial/left lateral, catalog#: 00584201202, lot:# 63006783.Investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).

Event Description

It was reported that patient underwent a partial knee arthroplasty procedure.Subsequently, patient started experiencing pain on the outside of the affected right knee.Surgeon stated that the device had loosened.It is unknown whether the patient has been revised.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

Concomitant medical products: stryker simplex bone cement with tobramycin, stryker asymmetric patella.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a partial knee arthroplasty procedure.Subsequently, patient started experiencing pain on the outside of the affected right knee and instability.Surgeon stated that the device had loosened.Patient was revised with all prostheses removed.

Manufacturer Narrative

Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-04143, 0001822565-2019-02472, and 0001822565-2019-02473.This follow-up report is being submitted to relay additional information.Reported event was confirmed via operative notes.Device history record was reviewed and no discrepancies were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified extensive osteolysis and subsequent loosening was present along the margins of the femoral component of the right knee medial unicompartmental arthroplasty.The femoral component was also noted to be obliquely oriented.No original post-operative images were available for comparison of the components alignment.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.

Event Description

It was reported that patient underwent a partial knee arthroplasty procedure.Subsequently, patient started experiencing pain on the outside of the affected right knee.Surgeon stated that the device had loosened.Review of radiographs indicated loosening of the femoral and tibial tray, as well as osteolysis.Patient was revised with all prostheses removed approximately two years one month post operative.

• Brand Name: TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 1
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7744595
• MDR Text Key: 115889267
• Report Number: 0001822565-2018-04143
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: PK033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• 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: 00584200102
• Device Lot Number: 62888066
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2019
• 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 Weight: 64