• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. STANDARD FEMORAL STEM EXCEPTION -CEMENTLESS- 5°42- 12/14 - LEFT S9 PROTHESIS, HIP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET FRANCE S.A.R.L. STANDARD FEMORAL STEM EXCEPTION -CEMENTLESS- 5°42- 12/14 - LEFT S9 PROTHESIS, HIP Back to Search Results
Catalog Number PS125Y09
Device Problem Osseointegration Problem
Event Date 03/16/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). List of associated products: cobalt chrome femoral head 5°42 ø28 / 0 / 12-14/ col moyen, reference (b)(4), batch 0000667029. Avantage reload acetabular cup / cementless / size 56, reference (b)(4), batch 0000633995. Avantage e1 insert size 56 ø 28, reference (b)(4), batch 0000662939. The received x-ray showed that the bone around the lower part of stem is overdeveloped for both hips. Therefore, the reported event is confirmed. The device will not be returned to the manufacturer. Therefore it will 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

The patient is part of a clinical study. On (b)(6) 2020, the surgeon provided delayed study data. It was reported that the patient suffers from cortical hypertrophy in zones 3 and 5 since (b)(6) 2016. According to the surgeon, the reported event could possibly be related to the procedure and definitely related to the stem.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTANDARD FEMORAL STEM EXCEPTION -CEMENTLESS- 5°42- 12/14 - LEFT S9
Type of DevicePROTHESIS, HIP
Manufacturer (Section D)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR  26903
Manufacturer (Section G)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR  26903
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key10027757
Report Number3006946279-2020-00101
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type STUDY
Reporter Occupation
Type of Report Initial
Report Date 05/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/2020
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2015
Device Catalogue NumberPS125Y09
Device LOT Number0000592504
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/22/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/02/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/06/2020 Patient Sequence Number: 1
-
-