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

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to increasing pain, elevated metal ions, and a periprosthetic greater trochanter fracture approximately 10 years post implantation.The patient had to use an ambulation aid due to the pain.During the revision, metallosis, fluid, loosening of acetabular and femoral components, osteolysis, and small anterior pseudotumor were noted.All implants were removed and replaced with competitor product.The fracture was reduced and stabilized with cables.Additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products : ref 0100214154, lot 2435698, acetabular cup.Ref 0100181480, lot 2435670, femoral head.Ref 0100185145, lot 2408136, femoral head adaptor.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h1, h2, h3, h6, h10 h6: component code: mechanical (g04)- stem medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an.The patient underwent a revision due to pain, elevated metal ions, and a periprosthetic fracture.During the revision, fluid was found in the joint related to metallosis.The stem was loose and a pseudotumor was found.All zimmer products were removed and replaced with competitor products.Reported event was confirmed by review of medical records provided.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Root cause could not 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 further event information available at the time of this report.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14515099
• Report Number: 0001822565-2022-01600
• Device Sequence Number: 5628880
• Product Code: LPH
• UDI-Device Identifier: 00889024131811
• UDI-Public: (01)00889024131811(17)310119(10)61158160
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K032726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00771101040
• Device Lot Number: 61158160
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2009
• 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: Male