MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD PS TIB BRG 16X79/83MM; PROSTHESIS, KNEE

Model Number 183666

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign.Customer has indicated that the product is in process of being returned to zimmer biomet for evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that upon receipt of an articular surface implant, the sterile packaging was found to be missing.There was no patient involvement and no adverse events have been reported as a result of the malfunction.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported correction does not alter previously reported investigation results.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.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.G2 : foreign country: germany.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.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.

Event Description

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

• Brand Name: VNGD PS TIB BRG 16X79/83MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16918201
• MDR Text Key: 315071913
• Report Number: 0001825034-2023-01039
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00880304272040
• UDI-Public: (01)00880304272040(17)271217(10)65817381
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 183666
• Device Catalogue Number: 183666
• Device Lot Number: 65817381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 08/09/2023; 08/09/2023
• Supplement Dates FDA Received: 08/31/2023; 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2022
• 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