MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET FINNED PRI STEM 40MM; PROSTHESIS KNEE

Model Number N/A

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

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: biomet ilok pri tib tray 71mm catalog # 141213 lot # 686560; vanguard cr ilok fem-rt 62.5 catalog # 183006 lot # j6555744; vngd cr lip tib brg 16x71/75mm catalog # 183546 lot # 324420.Series a pat std 34 3 peg catalog # 184766 lot # 613630; stryker cement catalog # unknown lot # unknown.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2021-02306, 0001825034-2021-02314, 0001825034-2021-02315, 0001825034-2021-02316.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was experiencing pain and a crooked knee post surgery.Additionally, the patient was walking differently.No revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical review indicates that patient states right knee is experiencing issues, and left knee has no issues.States walks differently now knee goes inward and lower leg goes outward.X-ray review indicates that right knee arthroplasty components are anatomically aligned.There is no fracture or evidence of implant loosening.There is mild asymmetric right knee valgus when compared to the left knee.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

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

• Brand Name: BIOMET FINNED PRI STEM 40MM
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12280841
• MDR Text Key: 265167580
• Report Number: 0001825034-2021-02317
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141314
• Device Lot Number: 978350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White