MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FEM STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, product was implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product was implanted.
Event or Problem Description
It was reported that during the procedure the doctor opened the package and noticed that there was a sticker sticking on m/l kinectiv stem.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Complaint was confirmed with a photograph of the product.Visual review identified the following: there was a sticker on the m/l taper stem.No further evaluation is possible using the photograph provided.Review of the device history records and packaging set up sheet identified no deviations or anomalies during manufacturing.The root cause can be attributed to manufacturing deficiency.A pqs-bwar-20-0328 was assigned for the reported issue.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: MODULAR FEM STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10712993
• Report Number: 0001822565-2020-03591
• Device Sequence Number: 3259548
• Product Code: LPH
• UDI-Device Identifier: 00889024132603
• UDI-Public: (01)00889024132603
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K182678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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: 00771300600
• Device Lot Number: 64602696
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 03/05/2021
• 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: NI
• Patient Sequence Number: 1