MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD - BIOMET TIBIAL TRAY; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Tingling (2171); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/05/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: vanguard ssk femur catalog # 185283 lot # 3458069, vanguard distal femur augment catalog # 185383 lot # 761510, vanguard distal femur augment catalog # 185403 lot # 960320, vg 360 univ pst fm aug catalog # 185343 lot # 144500, vg 360 univ pst fm aug catalog # 185343 lot # 917410, bmt splined knee stm catalog # 148316 lot # 070820, bmt offset adapter catalog # 185210 lot # 461680, bmt splined knee stm catalog # 148318 lot # 601210, bmt offset adapter catalog # 185210 lot # 461680, bmt tib aug catalog # 185233 lot # 754180, vngd ssk psc tib brg catalog # 183890 lot # 840400.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: 0001825034-2019-05413, 0001825034-2019-05414, 0001825034-2019-05420, 0001825034-2019-05421, 0001825034-2019-05423, 0001825034-2019-05424, 0001825034-2019-05425, 0001825034-2019-05427, 0001825034-2019-05428, 0001825034-2019-05429, 0001825034-2019-05430.Remains implanted.

Event Description

It was reported that the patient underwent a revision knee arthroplasty due to infection.Subsequently, the patient experienced tingling and numbness in the knee two weeks postoperatively.The patient was diagnosed with peripheral neuropathic pain treated with gabapentin, physical therapy and sleep medication.Within the postop follow up visits, the patient reported decreasing ambulation, increased pain, and the need for assistive device to ambulate.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Joint assist review indicates patient was diagnosed with peripheral neuropathic pain related to an orthopedic replacement.At 1 year visit patient reported moderate pain and using a cane.At 2 year visit patient still had pain and was using crutches or a walker.At 3 year visit patient continued to have pain, difficulty walking and was housebound.Official medical records were not provided.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: VANGUARD - BIOMET TIBIAL TRAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9399668
• MDR Text Key: 168796550
• Report Number: 0001825034-2019-05426
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K093293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• 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: 185203
• Device Lot Number: 354030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2020
• 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): Required Intervention
• Patient Weight: 94