MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE C; PROSTHESIS, KNEE

Catalog Number 42532006402

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that there was foreign material inside the inner package.A new device was opened and used to complete the procedure.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device confirmed that a hair was present between the foam protector and the inner cavity.The hair was found on the outside of the poly bag the product is packaged in.Dhr was reviewed and no discrepancies were found.The root cause of this issue was determined to be human error as this non-conformance was not detected as part of the inspection steps detailed in the packaging procedure.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 information available.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE C
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 7802789
• MDR Text Key: 117848263
• Report Number: 3007963827-2018-00137
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42532006402
• Device Lot Number: 63961151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1