MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. EXCEPTION STEM HAP SIZE 4; COATED HIP FEMUR PROSTHESIS, MODULAR

Catalog Number NOT COMMUNICATED

Device Problem Biocompatibility (2886)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).List of associated devices: avantage cup, reference and batch not communicated; 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

It was requested by the poison control center of (b)(6) the composition of products biomet exception hap n°4 - cupule avantage biomet e1 50 22 col metal court.Indeed, these products were recorded with undesirable events.No more information provided.

Manufacturer Narrative

(b)(4).No further information provided (x-rays, surgical report, photographs, lab test).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 medical reaction: 12 complaints (12 products), this one included, have been recorded on exception stem, from (b)(6) 2018 to (b)(6) 2021.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, root cause of the event was unable to be determined.However, there is no evidence that the event is related to the product.A summary of the investigation has been sent to the customer.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

T was requested by the poison control center of paris the composition of products biomet exception hap n°4 - cup avantage biomet e1 50 22 neck metal short.Indeed, these products were recorded with indesirable events.No more information provided.

• Brand Name: EXCEPTION STEM HAP SIZE 4
• Type of Device: COATED HIP FEMUR PROSTHESIS, MODULAR
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 12171863
• MDR Text Key: 261652885
• Report Number: 3006946279-2021-00111
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: NOT COMMUNICATED
• Device Lot Number: NOT COMMUNICATED
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ASSOCIATED DEVICES LISTED IN H10
• Patient Outcome(s): Other