MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. DISTAL PLUG PE 11MM; N/A

Catalog Number 4341

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign, event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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 has been reported by the hospital that the patient underwent initial partial hip prosthesis surgery in 2014 due to a fracture.In that first surgery of (b)(6) 2014 it was implanted a bipolar cup (ringloc), a cocr head, a taperloc hip stem cocr, a distal plug, and biomet plus bone cement.The patient underwent a second intervention due to pain during which bipolar cup was revised and the ringloc was in bad condition in (b)(6) 2018.This report is based on allegations set forth in hospital's notice and the allegations there in are unverified.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : h2 h10.The product analysis can't be performed as the product was not returned.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.1 complaint, this one included, has been recorded on distal plug pe 11mm, reference 4341, from 7 october 2016 to 03 june, 2020.1 complaint, this one included, has been recorded over the batch 0000924689.With the available information, the exact root cause of the event could not 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 by the hospital that the patient underwent initial partial hip prosthesis surgery in 2014 due to a fracture.In that first surgery of (b)(6) 2014 it was implanted a bipolar cup (ringloc), a cocr head, a taperloc hip stem cocr, a distal plug, and biomet plus bone cement.The patient underwent a second intervention due to pain during which bipolar cup was revised and the ringloc was in bad condition in (b)(6) 2018.This report is based on allegations set forth in hospital's notice and the allegations there in are unverified.

• Brand Name: DISTAL PLUG PE 11MM
• Type of Device: N/A
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 9574885
• MDR Text Key: 174709165
• Report Number: 3006946279-2020-00003
• Device Sequence Number: 1
• Product Code: LPH
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 4341
• Device Lot Number: 0000924689
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization