MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA THE PERSONALIZED KNEE SYSTEM VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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.Will be returned.

Event Description

It was reported that a possible hair was seen on a patella that was prepared for a total knee arthroplasty when the nurse opened the package.Subsequently, another patella was used for the operation.

Manufacturer Narrative

(b)(4).Reported event was considered confirmed as visual evaluation of the product identified a hair-like substance.Both the sterile packaging's have been opened when returned.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause of the reported event cannot 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.

Event Description

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

• Brand Name: PERSONA THE PERSONALIZED KNEE SYSTEM VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 8477643
• MDR Text Key: 140738980
• Report Number: 0002648920-2019-00247
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 42540200029
• Device Lot Number: 64150512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1