MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE XR MP T1 PPS 10X105MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# ep-200144 lot# 66231577 act artic e1 hip brg 28x38mm.Cat# 163662 lot# 65832763 28mm mod hd std neck tp1 taper.G2: foreign ¿ australia.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient was revised one week post-implantation due to the stem coming through the posterior cortex of the femur.The patient was revised to a full length stem with cable.The head and bearing were also revised.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical: stem.One item was returned and evaluated.Upon visual inspection there is scuffing to the taper of the device.There are also scratches to the taper and to the area around the hole.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and review identified findings of the reported issues: left total hip arthroplasty with periprosthetic fracture involving the posterior aspect of the proximal femoral diaphysis with associated angulation of the femoral stem.A definitive root cause cannot be determined.The event is confirmed via x-ray review.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 information is available at the time of this report.

• Brand Name: TAPERLOC COMPLETE XR MP T1 PPS 10X105MM
• 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: 19331015
• Report Number: 0001825034-2024-01249
• Device Sequence Number: 7003622
• Product Code: LPH
• UDI-Device Identifier: 00880304517295
• UDI-Public: (01)00880304517295(17)330220(10)7448345
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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 Model Number: N/A
• Device Catalogue Number: 51-145100
• Device Lot Number: 7448345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female