MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE XR 123 FEMORAL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Ambulation or Postural Difficulties (2544)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat: 12-115123; lot: 2898724; cer bioloxd mod hd 36mm +6 nk.Cat: 010000859; lot: 3429044; g7 neutral e1 liner 36mm g.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was kept by the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately six years post-implantation, the patient underwent a right hip revision due to stem fracture.The patient was walking and felt a sudden snap and pain in their leg.Radiology revealed the stem fracture and heterotopic ossification around the grater trochanter.During surgery, the stem was found broken at the base of the neck and the broken femoral neck and head were inside the acetabular socket.A significant amount of scar tissue was excised.The shell remained implanted and all other components revised.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6 visual examination of provided pictures identified a fracture of the stem at the level of the neck.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and review of the available records identified the following: patient had a right total hip arthroplasty.Patient was on vacation, was walking when he felt his right hip snap and immediately give out, then unable to walk.Ct findings: discontinuity of the right femoral stem hardware suggesting failure/breakage.No evidence of underlying acute bony fracture or soft tissue collections.X-ray findings: heterotopic ossification around the greater trochanter.Fractured right hip arthroplasty hardware.Findings during revision: femoral stem broken at the base of the neck.Patient presented with pain after his leg giving out 6 days prior.Significant amount of scar tissue and scarred capsule was excised.The broken femoral neck and head were inside the acetabular socket.Shell cleared by excising overlying bone and left in place, high wall poly placed.Femoral component removed (without osteotomy) and stem placed without complications.No concerns on postop xray.No other contributing factors were noted.A definitive root cause cannot be determined.Based on the provided images of the fractured stem and medical records, the complaint is confirmed.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: TAPERLOC COMPLETE XR 123 FEMORAL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20457400
• Report Number: 0001825034-2024-02436
• Device Sequence Number: 7794212
• Product Code: LZO
• UDI-Device Identifier: 00880304517158
• UDI-Public: (01)00880304517158(17)270902(10)6121909
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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 Model Number: N/A
• Device Catalogue Number: 51-105140
• Device Lot Number: 6121909
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2017
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 106 KG