MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD PS TIBIAL BEARING; PROTHESIS KNEE

Catalog Number EP-183660

Device Problem Unstable (1667)

Patient Problems Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unique identifier (udi) #: n/a.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Associated product: item # 184770, lot # 079600; item # 183214, lot # 094410; item # 141228, lot # j2375563.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.

Event Description

It was reported patient underwent right knee arthroplasty.Subsequently patient experienced pain and swelling two years after implantation.Patient underwent a revision later due to possible loosening.Only the bearing was revised as the other components were not determined to be loose.

Event Description

It was reported patient underwent right knee arthroplasty.Subsequently patient experienced pain and swelling two years after implantation.Patient subsequently underwent a revision procedure five (5) years post-implantation due to pain, instability, and limited range of motion in extension.A posterior capsular release was also performed to improve range of motion.Only the bearing was revised as the other components were not determined to be loose.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of op notes which indicated varus/valgus instability and decreased extension were noted intra-operatively.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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 PS TIBIAL BEARING
• Type of Device: PROTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7786579
• MDR Text Key: 117256721
• Report Number: 0001825034-2018-04388
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: PK171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: EP-183660
• Device Lot Number: 982480
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 100