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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 - RIGHT S9 PROTHESIS, HIP

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BIOMET FRANCE S.A.R.L. STANDARD FEMORAL STEM EXCEPTION -CEMENTLESS- 5°42- 12/14 - RIGHT S9 PROTHESIS, HIP Back to Search Results
Catalog Number PS126Y09
Device Problem Osseointegration Problem
Event Date 04/28/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). List of associated products: - cobalt chrome femoral head 5°42 ø28 / 0 / 12-14/ col moyen, reference p0206m28, batch 0000688388. - avantage reload acetabular cup / cementless / size 58, reference p0460p58, batch 0000467530. - avantage e1 insert size 58 ø 28, reference p0561e58, batch 0000645527. The received x-ray showed that the bone around the lower part of the stem is overdeveloped for the right hip. 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

It was reported that the patient is a (b)(6) year-old male who is part of a clinical study. On (b)(6) 2020, the surgeon provided delayed study data, and it was noticed that the patient suffers from cortical hypertrophy in zones 3 and 5 since (b)(6) 2017. The surgeon provided an xray dating from (b)(6) 2019. According to the surgeon, the reported event could possibly be related to the procedure and definitely be related to the stem.

 
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Brand NameSTANDARD FEMORAL STEM EXCEPTION -CEMENTLESS- 5°42- 12/14 - RIGHT 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 Key10027784
Report Number3006946279-2020-00054
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
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2014
Device Catalogue NumberPS126Y09
Device LOT Number0000419463
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 Received04/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/04/2009
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
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