MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. MODULAR HEAD COCR 28MM MEDIUM; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Hip Fracture (2349)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient had underwent a surgery on (b)(6) 2018 due to the fracture of the femoral neck has been revised on (b)(6) 2018 due to a periprosthetic fracture.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: bi-polar 28 cup 49mm, reference : 165222 , lot number : 6219474.Cocr hd md nk 28 std 12/14, reference : p0206m28 , lot number :j6059952.3006946279-2019-00016 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that the patient had underwent a surgery on (b)(6) 2018 due to the fracture of the femoral neck has been revised on (b)(6) 2018 due to a periprosthetic fracture.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The product analysis can't be performed as the product was not returned the device manufacturing quality record indicates that the released product met all requirements to perform as intended.According to available data, the exact root cause can¿t 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

It has been reported that the patient had underwent a surgery on (b)(6) 2018 due to the fracture of the femoral neck has been revised on (b)(6) 2018 due to a periprosthetic fracture.

• Brand Name: MODULAR HEAD COCR 28MM MEDIUM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8231634
• MDR Text Key: 132532718
• Report Number: 3006946279-2019-00016
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03599870003275
• UDI-Public: (01)03599870003275
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2019

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 Expiration Date: 05/29/2022
• Device Model Number: N/A
• Device Catalogue Number: P0206M28
• Device Lot Number: J6059952
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 01/09/2019
• Supplement Dates Manufacturer Received: 12/07/2018; 07/02/2019
• Supplement Dates FDA Received: 03/13/2019; 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 90 YR