MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL KNEE ARTICULAR SURFACE ULTRACONGRUENT SIZE 00 0; PROSTHESIS KNEE

Model Number N/A

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

Patient Problems Pain (1994); Increased Sensitivity (2065); Numbness (2415)

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 remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: nonporous stemmed tibial baseplate size 0 right item # 360701200 lot # 60809762, gender solutions female (gsf) femoral component nonporous size 1, right item # 0054141402 lot # 60811421, gender solutions female (gsf) femoral component nonporous size 1, right item # 00542000800 lot # 60830621.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05310, 0001822565-2018-05311, 0001822565-2018-05312.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 right total knee arthroplasty and subsequently has been experiencing numbness, tingling, pain and a feeling that devices are too large for her body.

Event Description

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

Manufacturer Narrative

(b)(4).Medical product palacos rg cement, catalog #: 00111314001 lot #: 66234138 reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Root cause was unable to 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: NATURAL KNEE ARTICULAR SURFACE ULTRACONGRUENT SIZE 00 0
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7917776
• MDR Text Key: 121999889
• Report Number: 0001822565-2018-05313
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK070214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Model Number: N/A
• Device Catalogue Number: 00542802009
• Device Lot Number: 60839752
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2019
• 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: 57