MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEUTRAL LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2020

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 during a hip procedure, a hair was found inside the sterile packaging when the implant was opened.There was no direct contact with the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1; a3; g4; h2.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Complaint sample was returned and evaluated against the reported event.Visual evaluation of the returned product confirmed the presence of a hair-like fiber, about 100 mm long, in the inner sterile cavity, which had been fully opened prior to return.No other damage or anomalies were noted.Complaint is confirmed.Dhr was reviewed and no discrepancies were found.The likely condition of the part when it left zimmer biomet control cannot be evaluated.It cannot be determined if the hair like fiber was introduced in the transparent sterile cavities before or after the product was fully opened.A definitive root cause 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: NEUTRAL LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10450831
• MDR Text Key: 204336873
• Report Number: 0001822565-2020-03049
• Device Sequence Number: 1
• Product Code: OQG
• UDI-Device Identifier: 00889024155008
• UDI-Public: (01)00889024155008
• Combination Product (y/n): N
• PMA/PMN Number: K120370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00885101136
• Device Lot Number: 64030822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1