MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER NEUTRAL 36 MM I.D. SIZE JJ FOR USE WITH 54 MM O.D. SIZE JJ SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.(b)(4).

Event Description

During surgery upon opening the implant a human hair was found in the packaging.The surgery was completed with another product after a five minute delay.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The hair and package were received separately.Visual inspection of the returned product found that, the liner is undamaged and shows no signs of contamination or use.Device history record was reviewed and no discrepancies were found.A definitive root cause for this issue attributed to be human factors issue.A summary of the investigation has been sent to the complainant.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Further investigation determined the product likely left zimmer biomet control non-conforming.Based on the confirmed presence of a hair in the package, it was concluded that it was due to a manufacturing deficiency.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: LINER NEUTRAL 36 MM I.D. SIZE JJ FOR USE WITH 54 MM O.D. SIZE JJ SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 6151519
• MDR Text Key: 61715520
• Report Number: 0002648920-2016-04369
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK091508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00875101136
• Device Lot Number: 63306302
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Date Manufacturer Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1