MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 9X137MM; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a primary hip arthroplasty.It was reported that the patient suffered an iatrogenic fractured that propagated post operatively.The patient was revised twenty-four (24) days post implantation.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia.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.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h3, h6 proposed code: mechanical (g04) ¿ stem no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for these items and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single limited ap bilateral hip film demonstrates a right total hip arthroplasty with incomplete evaluation of the acetabular portion.Acetabular inclination angle is approximately 59°.No fracture seen.Single ap view of the right hip demonstrates a right total hip arthroplasty.Oblique periprosthetic fracture involving the medial cortex of the proximal femoral diaphysis.A definitive root cause cannot be determined.Based on the provided radiographs, the complaint is confirmed.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.

• Brand Name: TPRLC XR T1 PPS 9X137MM
• Common Device Name: PROSTHESIS, HIPS
• 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: 20521413
• Report Number: 0001825034-2024-02508
• Device Sequence Number: 8638889
• Product Code: LPH
• UDI-Device Identifier: 00880304517103
• UDI-Public: (01)00880304517103(17)310909(10)7057078
• 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): 01/09/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 51-105090
• Device Lot Number: 7057078
• 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: 09/29/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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 Age: 72 YR
• Patient Sex: Female