MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M/L TAPER; PROTHESIS, HIPS

Model Number N/A

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

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

Event Date 02/24/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: unknown zimmer triology acetabular component, size 58mm unknown.Unknown zimmer longevity size 40mm unknown.Unknown zimmer/biomet delta ceramic femoral head size 40mm by 0mm unknown.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: op record reviewed -- record is incomplete list of components and positioning for the procedure listed.Due to the limited information provided no timeline was created.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic fracture of the proximal right femur with femoral implant loosening and subsidence.A definitive root cause cannot be determined.It was reported the patient fractured their femur due to a fall, however the reason for the fall is unknown.This complaint was confirmed based on the provided x-rays.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

It was reported that the patient was implanted with unknown zimmer biomet products.Subsequently, the patient was revised due a periprosthetic fracture from a fall.It was reported the patient had limited mobility and the implant did not contribute to the fall.

• Brand Name: UNKNOWN M/L TAPER
• Type of Device: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18889255
• MDR Text Key: 337483025
• Report Number: 0001822565-2024-00857
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNK M/L TAPER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2024
• Initial Date FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 90 YR
• Patient Sex: Male