MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Joint Dislocation (2374); Metal Related Pathology (4530)

Event Date 12/07/2023

Event Type  Injury  

Event Description

It was reported that the patient was revised approximately twelve years post-implantation due to a dislocation.During the revision surgery, the surgeon noticed trunion wear and a pseudotumor possibly due to metal ion release.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 03824; 0001822565 - 2023 - 03825.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• 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: 18418149
• MDR Text Key: 331586124
• Report Number: 0001822565-2023-03826
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024131781
• UDI-Public: (01)00889024131781(17)201130(10)61636761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192660
• 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: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00771101000
• Device Lot Number: 61636761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2023
• 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 Sex: Female
• Patient Weight: 84 KG