MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER SIZE 7.5 STANDARD OFFSET REDUCED NECK; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been returned to zimmer biomet for investigation.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 an initial hip procedure the surgical team went to open a m/l taper stem, and there was no glue on the plastic container sealing the paper to the plastic.The paper was not tightly sealed to the plastic holding containing the implant.It was decided not to use the implant due to uncertainty of sterility.No adverse events have been reported as a result of this malfunction.Attempts were made to obtain additional information; however, none was available.
Additional Manufacturer Narrative
Reported event was confirmed by visual examination of the device/packaging.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to a manufacturing error.Visual evaluation of the returned product confirmed that no glue was applied to the sealing flange of the inner sterile cavity and the inner lid was not attached to the inner cavity.The sterility is compromised.The likely condition of the part when it left zimmer biomet control is considered non-conforming based on the evaluation of the returned product.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: FEMORAL STEM 12/14 NECK TAPER SIZE 7.5 STANDARD OFFSET REDUCED NECK
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9864946
• Report Number: 0001822565-2020-00949
• Device Sequence Number: 16863509
• Product Code: LPH
• UDI-Device Identifier: 00889024131712
• UDI-Public: 00889024131712
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K032726
• 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
• Report Date (Section B): 07/28/2020

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 Model Number: N/A
• Device Catalogue Number: 00771100710
• Device Lot Number: 64504862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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