MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER NEUTRAL 32 MM I.D. SIZE; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that there was debris in the sterile packaging.Additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  the following sections were  updated: b4, b5, d10, g4, g7, h1, h2, h3, h6, h10.Visual examination of the returned product confirmed the presence of a hair-like fiber within the sterile packaging, which had been opened prior to return as evidenced by the blood stains found on the cavity and partially peeled off tyvek lid.Therefore, the complaint cannot be confirmed.Device history record was reviewed and no discrepancies were found.The likely condition of the part when it left zimmer biomet control cannot be evaluated because the packaging was opened.Root cause was unable to 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: LINER NEUTRAL 32 MM I.D. SIZE
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9637540
• Report Number: 0001822565-2020-00372
• Device Sequence Number: 2800435
• Product Code: LPH
• UDI-Device Identifier: 00889024149083
• UDI-Public: (01)00889024149083(17)220331(10)63619410
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00875100832
• Device Lot Number: 63619410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/19/2020
• 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