MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD PS TIB BRG 71/75X10; PROSTHESIS KNEE

Model Number N/A

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

Patient Problems Muscular Rigidity (1968); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of birth: (b)(6).Implant date - unknown month and day in 2014.Event date and explant date - unknown month and day in 2017.Medical products: series a pat thn 34 3 peg, catalog # 184786, lot # unknown; tinbn vg int ps anat fm l 65mm ,catalog # 183128tnbn, lot # unknown; tnbn pol cocr fin tib tray 71, catalog # 141253tnbn, lot # unknown.Customer has indicated that the product will not be returned because product location is unknown.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: 0001825034-2021-02130.Product location is unknown.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was revised due to pain.It is unknown what products were revised.Attempt for further information has been made, but no further information has been provided.

Event Description

From additional information, it was reported that the patient presented with joint stiffness and a low range of motion, which is why arthrolysis, a maquet osteotomy and a patella baja were all performed.It was confirmed that the patient did not have a revision of zimmer biomet product.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported patient underwent a revision procedure post implantation due to pain.The patient had joint stiffness and a low range of motion, which is why arthrolysis, a maquet osteotomy and a patella baja were all performed.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.Medical records review indicates there is chronic pain due to complication with patella resurfacing caused by avascular necrosis.Patient was revised in 2017 in a different hospital than the study center and reported chronic pain after revision.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: E1 VNGD PS TIB BRG 71/75X10
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12216713
• MDR Text Key: 263096732
• Report Number: 0001825034-2021-02131
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• 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: EP-183640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 66