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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AVANTAGE INLAY S54 / 28 NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER

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BIOMET FRANCE S.A.R.L. AVANTAGE INLAY S54 / 28 NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER Back to Search Results
Catalog Number P0561054
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 12/15/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source, foreign - event occurred in (b)(6). Concomitant medical products - list of associated devices: cobalt chrome femoral head 5°42 ø28 / 0 / 12-14/ col moyen, reference (b)(4), batch j6787299. 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 there was an intraprosthetic dislocation of the right total hip prosthesis.
 
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Brand NameAVANTAGE INLAY S54 / 28
Type of DeviceNON-CONSTRAINED POLYETHYLENE ACETABULAR LINER
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 Key13106207
MDR Text Key282893504
Report Number3006946279-2021-00213
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberP0561054
Device Lot Number0001511683
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/29/2021 Patient Sequence Number: 1
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