MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Loss of Range of Motion (2032)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: persona femur cruciate retaining (cr) catalog 42502206402 lot 64071413, nexgen complete knee solution, trabecular metal patella catalog 00587806532 lot 64176468, natural tibia trabecular metal fixed bearing right size d catalog 42530006702 lot 62869826.The product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04181, 0001822565-2019-04182.

Event Description

A patient enrolled in a clinical study underwent right knee arthroplasty and was noted to have stiffness and decreased range of motion during their one month follow-up visit.Patient underwent a manipulation under anesthesia approximately two weeks later.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of the available records by a health care professional noted the patient experienced stiffness requiring manipulation under anesthesia.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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.

Event Description

No additional information reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

A patient enrolled in a clinical study underwent right knee arthroplasty and was noted to have stiffness and decreased range of motion during their one month follow-up visit.Patient underwent a manipulation under anesthesia approximately two weeks later and again approximately one month later.Patient continues to have pain and stiffness as of the three month follow up.

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9134990
• MDR Text Key: 160847453
• Report Number: 0001822565-2019-04181
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00889024468177
• UDI-Public: (01)00889024468177
• Combination Product (y/n): N
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2020

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 Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42522100110
• Device Lot Number: 63753017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 12/11/2019; 02/27/2020
• Supplement Dates FDA Received: 01/06/2020; 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 69