MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM - REVISION TAPER - NITRIDED CEMENTLESS; PROSTHESIS HIP

Catalog Number	00998201718
Medical Device Problem Codes	Material Erosion (1214); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Item# 00999301835/ femoral body - revision - nitrided - porous cementless 12/14 neck taper extended / lot # 62734829.Item # 00877503602 / bioloxâ® delta, ceramic femoral head,/lot # 2787769.(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2021 - 03132.
Event or Problem Description
It was reported that patient underwent a revision surgery 6 years post implantation.Patient reported feeling right leg pain playing golf.X-ray revealed reveled a fracture around the junction of the zmr stem and zmr body.Patient had previous peri-prosthetic fracture due to a fall (stryker product insitu) which was replaced with a zmr construct.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional information on the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed via pictures, medical records, and radiographs that were reviewed by a health care professional.Visual examination of the provided pictures identified the femoral body fractured off the stem.Products were covered in bio debris.No further evaluation can be made from the provided pictures.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.A definitive root cause cannot be identified.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that patient underwent a revision surgery 6 years post implantation as the patient reported feeling right leg pain playing golf.X-ray revealed a fracture around the junction of the zmr stem and zmr body.Patient had previous peri-prosthetic fracture due to a fall (stryker product insitu) which was replaced with a zmr construct.It was noted in an implant report failure to osteointegration, implant wear, and implant corrosion.There is no additional 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/corrected updated: h6 proposed component code: mechanical (g04)- stem.Visual examination of the provided pictures within the citra report identified the fractured distal stem showing gross corrosion with larger corrosion pits.The proximal body also shows crevice corrosion on the surface and wear, with minimal traces of fibrous tissue to ongrowth surface.The stem was submitted for further analysis by australia through the citra lab.Analysis determined the stem fractured due to fatigue fracture with the initiation point on the lateral edge.Corrosion was identified around the fractured surface.Review of complaint history found no additional related issues for this item and the reported part and lot combination.The root cause of the reported issue is attributed to user error, as the surgeon placed the zmr in a femur without enough proximal support, which was noted in the citra report.While the corrosion contributed to the failure, the surgeon did not follow the zmr surgical technique, that the zmr xl should be considered in cases in which proximal support cannot be achieved.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.This complaint was confirmed based on the provided records, photos, and the citra report.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
There is no update to the prior event description provided.

• Brand Name: FEMORAL STEM - REVISION TAPER - NITRIDED CEMENTLESS
• 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: 12727746
• Report Number: 0001822565-2021-03130
• Device Sequence Number: 1440798
• Product Code: JDI
• UDI-Device Identifier: 00889024160828
• UDI-Public: (01)00889024160828(17)250331(10)62934983
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 00998201718
• Device Lot Number: 62934983
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 12/15/2021; 08/30/2023; 01/16/2024
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 12/28/2021; 09/14/2023; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2015
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Race: White