MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 02/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2019-00087, 0001822565-2019-01354.Concomitant medical products: partial femur cemented size 5 right medial, item# 42558000502, lot# 63602080 ; partial articular surface right medial, item# 42528200509, lot# 63435460.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient had right partial knee implanted and subsequently, during a clinical visit, patient is experiencing severe pain to the right knee and problems with ambulation and stiffness.There is no additional information at this time.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: date of report, description of event or problem, device identification, date received by mfr, type of report, type of reportable event, follow up type, device evaluated by mfr, evaluation codes, and additional narrative.Corrected: adverse event.The reported event was confirmed through patient notes.No complications were noted in crf.Office visit note states that patient had moderate pain.Another office visit note states that patient had extreme pain, stiffness and difficulty in ambulation.The rom was noted to be 110 degrees.X-ray review by third party hcp states that slight rotation of the femoral component and slight subsidence of the tibial component occurred resulting in malalignment as described.Slight worsening in the medial patellofemoral joint arthrosis.There is also worsening of the contralateral left knee arthrosis.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.It was noticed in the x-ray evaluation that there is arthrosis seen in the knee which can be a contributing condition.However, a 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: PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8469132
• MDR Text Key: 140446471
• Report Number: 0001822565-2019-01353
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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 Model Number: N/A
• Device Catalogue Number: 42538000502
• Device Lot Number: 63807406
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 112