MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE D 10 MM THICKNESS; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Osteopenia/ Osteoporosis (2651); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: 42538000401 - tibial component - 63755573; 42558000301 - femoral component - 64465213; 110034355 - refobacin bc r 1x40 us - 835aae2507.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03212, 3007963827-2020-00221.

Event Description

It was reported that the patient underwent an initial left unilateral knee arthroplasty.Subsequently, the patient experienced a fall three weeks post op.Approximately 2 months post implantation, the patient was revised due to difficulty ambulating, decrease in activity of daily living, pain, swelling, radiolucency, a periprosthetic fracture, loosening, subsidence, and poor bone quality.

Event Description

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE D 10 MM THICKNESS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10524461
• MDR Text Key: 206744373
• Report Number: 0001822565-2020-03213
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304818071
• UDI-Public: (01)00880304818071(17)220831(10)63755573
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42518200410
• Device Lot Number: 63755573
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2020
• 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: 90