MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP 12/14 PPS SO 11.0; PROSTHESIS, HIP

Catalog Number 51-120110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).A2: year of birth 1935.D10: medical product: g7 bispherical shell 52e: catalog#110017332, lot#6229808; g7 neutral arcomxl lnr 32mm e: catalog#010000732, lot#6243307; delta cer fm hd 032/-4.0 12/14: catalog#650-0833, lot#2018040333.G2: foreign: germany.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported via a clinical study that a patient underwent an initial left total hip arthroplasty.Subsequently, three (3) years and five (5) months post-implantation, the patient underwent revision surgery due to acetabular cup loosening and a periprosthetic bone fracture of the greater trochanter.All components were revised without reported complication.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) - stem.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: acetabular loosening and periprosthetic greater trochanter fracture.Root cause was unable to be determined.Reported event was confirmed by review of provided medical records.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.

Event Description

No further event information at time of this report.

• Brand Name: TPRLC 133 FP 12/14 PPS SO 11.0
• Type of Device: 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: 18312986
• MDR Text Key: 330301202
• Report Number: 0001825034-2023-02958
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 51-120110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 58 KG