MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 TYPE1 BM HO 13.0; PROSTHETIC, HIP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 11/10/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure 16 days post implantation due to stem subsidence that occurred due to a femoral fracture due to the patient falling.Cemented stem required to bypass fracture, conversion to dm.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).G2: foreign: australia.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Bone fracture was confirmed based on evaluation of the provided x-rays.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall fit and alignment of the implant is appropriate.Periprosthetic fracture along what appears to the be the posterior aspect of the tip of the femoral stem.Subsidence not confirmed on these images.A definitive root cause cannot 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 Description

There is no update to the prior event description provided.

• Brand Name: TPRLC 133 TYPE1 BM HO 13.0
• Type of Device: PROSTHETIC, 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: 18256682
• MDR Text Key: 329608782
• Report Number: 0001825034-2023-02817
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304521407
• UDI-Public: (01)00880304521407(17)330821(10)7546060
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 51-114130
• Device Lot Number: 7546060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female