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

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
No additional event information to report at this time.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: NEUTRAL LINER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10450831
• Report Number: 0001822565-2020-03049
• Device Sequence Number: 4044544
• Product Code: OQG
• UDI-Device Identifier: 00889024155008
• UDI-Public: (01)00889024155008
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 09/01/2020; 11/12/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/22/2020; 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1