MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD POSTERIOR STABILIZED TIBIAL BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problems Pitted (1460); Naturally Worn (2988)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: biomet splined knee stem, cat#: 141656 lot#: 645660.Vanguard ssk interlok femoral, cat#: 183326 lot#: 181120.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-08332, 0001825034-2017-08334, 0001825034-2017-08335.Product location unknown.

Event Description

It was reported that the patient was revised to address pain, osteolysis and loosening of the stem and femoral.The polyethylene bearing also showed signs of pitting and wear.Attempts have been made and no further information has been provided.

Manufacturer Narrative

The follow-up report is being submitted to relay correction and additional information.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 also reported there was a slight delay in trying to repair a slight fracture due to bone loss.

Manufacturer Narrative

This follow up report is being supported to report additional information concomitant products- 185100 name: vngd ssk ps tib brg 10x79/83 lot: 539800; 141656 name: bmt splined knee stm 16x120 lot: 645660; 183326 name: vngd ssk intlk fmrl 70 lt lot: 181120; 184166 name: vngd post fem aug 70x5 ll/rm lot: 668840; 184126 name: vngd dist fem aug 70x5 ll/rm lot: 897770; 184146 name: vngd post fem aug 70x5 rl/lm lot: 854490; 141516 name: biomet ilok stem tib tray 83mm lot: 081270; 184607 name: rgx cone aug por ti 40mm med lot: 004300; 141652 name: bmt splined knee stm 12x120 lot: 992860.Reported event was confirmed through radiographs received.Product was not returned for evaluation.X-ray review report indicates presents of luncency surrounding the femoral stem.Osteopenia.Normal anatomy.No fracture seen.No evidence of wear or debris.Device history record (dhr) was reviewed and no discrepancies were found.Review of complaint history determined that no further action is required.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 POSTERIOR STABILIZED TIBIAL BEARING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6946064
• MDR Text Key: 89342328
• Report Number: 0001825034-2017-08332
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 185100
• Device Lot Number: 539800
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR