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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: catalog number:00875101240 lot number: 64551639 brand name: acetabular liner; catalog number:00877504002 lot number:3009340 brand name: biolox head; catalog number: 00875705601 lot number: 64630388 brand name: acetabular cup.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.
Event or Problem Description
It was reported that the patient experienced severe pain and was diagnosed with trochanteric bursitis approximately 6 months post implantation.The surgeon recommended physical therapy, rest, and ice.The outcome was tolerated, and the patient showed improvement at the 1 year follow up with moderate pain.Additional information on the reported event is unavailable.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 02910.0001822565 - 2021 - 02911.G2: study: mymobility.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Medical records identified the following: the patient underwent an initial total hip arthroplasty due to osteoarthritis.Zimmer biomet components were implanted without any complications.The patient later had severe pain and trochanteric bursitis.The physician recommended seeing a pt along with icing the hip and more rest.No other finding/complication related to the reported event was noted.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, h1, h2, h10.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: FEMORAL STEM 12/14 NECK TAPER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12009241
• Report Number: 0001822565-2021-01626
• Device Sequence Number: 19935641
• Product Code: LZO
• UDI-Device Identifier: 00889024131859
• UDI-Public: (01)00889024131859(17)311025(10)63201856
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2021

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: 10/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00771101140
• Device Lot Number: 63201856
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 09/30/2021; 10/18/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 10/12/2021; 10/21/2021
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 84