MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00875705001-shell with cluster holes porous 50 mm o.D.Size hh for use with hh liners-63902206.00875100932-liner neutral 32 mm i.D.Size hh for use with 50 mm o.D.Size hh shell-63713720.00801803201-femoral head sterile product do not resterilize 12/14 taper-63416503.00625006530-bone scr 6.5x30 self-tap-63745006.00625006520-bone scr 6.5x20 self-tap-63919174.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03038, 0001822565 - 2021 - 03039, 0001822565 - 2021 - 03041, 0001822565 - 2021 - 03043, and 0001822565 - 2021 - 03044.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : device remains implanted.
Event or Problem Description
It was reported was reported patient returned to hospital 3 years post implantation due to right thigh pain that radiates to hip.The surgeon is uncertain if the event is related to the device.Treated initially with conservative monitoring, but since pain is persistent, imaging and bone scan taken with results pending at time of reporting.Patient reports continued severe pain.All workup for infection have been negative and reasons for the pain thus far inconclusive.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.Reported event was confirmed via medical records and radiographs reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.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 additional information on the reported event.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12671444
• Report Number: 0001822565-2021-03042
• Device Sequence Number: 13813366
• Product Code: LZO
• UDI-Device Identifier: 00889024131767
• UDI-Public: (01)00889024131767(17)260831(10)63433744
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K192660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00771100920
• Device Lot Number: 63433744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male