MAUDE Adverse Event Report: BIOMET GLOBAL SUPPLY CHAIN CENTER B.V. ZIMMER BIOMET OXFORD PARTIAL KNEE; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Patient Problems Failure of Implant (1924); Pain (1994); Joint Laxity (4526)

Event Date 06/08/2022

Event Type  malfunction  

Event Description

I am notifying the fda of a failed (partial knee revision).I had a zimmer biomet oxford partial knee replacement on (b)(6) 2022.By october 2022.I was still not recovering well.I had more pain than i should have.The knee was unstable and giving out.I called the doctor's office and notified them of the instability and the knee giving out.The doctor said he would not order tests to see why i was having a problem until i met a one year recovery duration.He told me he thought the pain was coming from rsd/crps and to see a neurologist.After the one year recovery.He ordered bone scan and ct scan.The scans show the implant is misaligned and 6 mm lucency and a second opinion doctor confirmed it and said it might also be too big.It has been recommended by the operating surgeon and a second opinion surgeon that i have a revision.The operating surgeon is concerned about redoing the knee because of the severe pain i experienced for several months afterwards and he didn't think he could provide the anesthesia needed.The second opinion surgeon recommended that i have the revision done in an academic setting so that i could be provided anesthesia that would help control pain and to prevent complex regional pain syndrome.I finally found an expert in rsd/crps doctor and he said he didn't think i have rsd/crps at this time and that the device was causing my pain.But, he did recommend that i have revision in academic setting to prevent rsd/crps.Device information: my doctor will not give me this information!.

• Brand Name: ZIMMER BIOMET OXFORD PARTIAL KNEE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): BIOMET GLOBAL SUPPLY CHAIN CENTER B.V.
• MDR Report Key: 18383726
• MDR Text Key: 331346994
• Report Number: MW5149465
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2023
• Patient Sequence Number: 1
• Treatment: CALCIUM CITRATE.; COLLAGEN.; GABAPENTIN.; LEFT KNEE IMPLANT (FAILED WITHIN ONE YEAR OF IMPLANTATION).; LEVOTHYROXINE.; RIGHT HIP IMPLANT.; TERBINAFINE.; TUMERIC.; VITAMIN D.; VOLTAREN GEL.; WALKING STICK ( DUE TO FAILED KNEE IMPLANT).
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White