MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO BI-METRIC POR FMRL NC 11X135MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial hip procedure.Five days post op, the patient developed pain and was unable to bear weight.The patient had no trauma or falls post initial surgery.A secondary x-rays showed that the stem had subsided.Subsequently, the patient underwent a revision procedure approximately 2 weeks post implantation.During the secondary procedure, a fracture was found, cabled and a bigger stem was reamed, broached, and inserted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: cat# 163670 lot# j7252771 32mm mod head cocr +3mm neck.Cat# 010000664 lot# 7586906 g7 pps ltd acet shell 54f.Cat# 010000928 lot# 7273204 g7 hi-wall e1 liner 32mm f.G2: foreign: new zealand.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: ECHO BI-METRIC POR FMRL NC 11X135MM
• 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: 19012190
• MDR Text Key: 339023402
• Report Number: 0001825034-2024-00867
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00887868260421
• UDI-Public: (01)00887868260421(17)321212(10)387520
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K070274
• 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
• Report Date: 03/27/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 192011
• Device Lot Number: 387520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization