MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. UPTION COMPLETE FEMORAL STEM; COAED HIP FEMUR PROTHESIS, MODULAR

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

Patient Problems Fall (1848); Hip Fracture (2349)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

A fracture of the greater trochanter was osteosynthesized by hook plate at 15 days postoperatively following a fall during rehabilitation.The current complaint comes from an article that has not been published yet and transmitted to zimmer biomet clinical department.

Manufacturer Narrative

(b)(4).No further information provided (x-rays, surgical report, photographs, lab test), therefore, the reported event could not be confirmed.The product analysis can't be performed as the product was not returned.The review of the device manufacturing quality can't be performed as the product reference and batch number was not communicated.A complaint extract was done regarding bone fracture: 1 complaint (1 product), this one included, has been recorded on uption complete femoral stem, from (b)(6) 2017 to (b)(6) 2020.- the complaint history, regarding the reference number, can't be performed as it was not communicated.The complaint history, regarding the batch number, can't be performed as it was not communicated according to available data, the most probable root cause of the bone fracture is the patient fall during the rehabilitation protocole.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 was reported a fracture of the greater trochanter was osteosynthesized by hook plate at 15 days postoperatively following a fall during rehabilitation.The current complaint comes from an article that has not been published yet and transmitted to zimmer biomet clinical department.

• Brand Name: UPTION COMPLETE FEMORAL STEM
• Type of Device: COAED HIP FEMUR PROTHESIS, MODULAR
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 10604929
• MDR Text Key: 209130134
• Report Number: 3006946279-2020-00194
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention