MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TIBIA; PROSTHESIS KNEE

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problems Pain (1994); Subluxation (4525); Swelling/ Edema (4577)

Event Date 04/03/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: persona articular surface medial congruent (mc) catalog # 42512100913, lot # 64625108.G2: australia.H3: 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.

Event Description

It was reported patient underwent a revision procedure nine months post implantation due to pain, swelling, range of motion and patella maltracking.Surgeon believes tibial rotation was not set correctly causing internal rotation with flexion and extension and this is causing the patella to sublux.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.D10: unknown patella catalog # unk, lot # unk.

Event Description

It was reported patient underwent a revision procedure nine months post implantation due to pain, swelling, range of motion and patella maltracking.Surgeon believes tibial rotation was not set correctly causing internal rotation with flexion and extension and this is causing the patella to sublux.Additionally, when the patient flexed the knee, the patella would temporarily dislocate causing the patient pain and discomfort.When patient extended the knee the patella would relocate, also with pain.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: UNKNOWN TIBIA
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19215166
• MDR Text Key: 341413103
• Report Number: 0001822565-2024-01439
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male