MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD TIBIA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Pain (1994); Osteolysis (2377)

Event Date 05/16/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2- germany.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : item number and lot number unknown.

Event Description

It was reported that 10 years after implantation of the unicondylar knee prosthesis on the right side, the patient is experiencing significant osteolysis in the tibial head.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

It was reported that the patient underwent an initial right partial knee, medial condylar arthroplasty on an unknown date six (6) years ago.Subsequently, the patient was converted to a total knee approximately two (2) months ago due to pain and cortical thinning of the tibia.During the revision, it was found that the implants were well fixed, but cystic formations were found at the medial tibia.All implants were replaced with competitor components.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device is used for treatment.Medical records were provided and reviewed by a hcp, findings as follows: revision due to pain and cortical thinning in the tibia.No evidence of infection, labs unremarkable.Implants well fixed, cortical thinning noted in the tibia cystic formations noted on the medial tibia.No comments regarding the appearance of the oxford implants.Implants removed without complication, competitor tka placed with navigation assistance.X-rays were provided and reviewed by a radiologist, findings as follows: x-rays about five (5) years after initial surgery - right knee medial unicompartmental arthroplasty components are anatomically aligned.There is extensive proximal tibial radiolucency reflecting osteolysis and minimal radiolucency is noted along the femoral implant.There is no implant displacement or evidence of loosening.There is mild knee varus.X-rays about six (6) years after initial surgery - no interval change in osteolysis.Slight increase in knee varus.With the available information, 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.H3 other text: item number and lot number unknown.

• Brand Name: UNKNOWN OXFORD TIBIA
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17152006
• MDR Text Key: 317544549
• Report Number: 3002806535-2023-00199
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 64 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 105 KG