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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC-S 60 REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC
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BIOMET FRANCE S.A.R.L. OPTIPAC-S 60 REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
Patient Problem Failure of Implant (1924)
Event Date 07/02/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Report source, foreign - event occurred in (b)(6). Concomitant medical products: avantage inlay s48 / 22,2, item: p0560048, lot: 0001102705; avantage cemented cup 48, item: p0463048, lot: 0001105980; optipac-s 60 refobacin bone cement r, item: 4711500396-1, lot: b708c05355; femoral stem 12/14, item: 00811400100, lot: 63735436; femoral head sterile 12/14, item: 00801802230 and lot: 63677745. The investigation is in progress. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that an initial left total hip arthroplasty was performed with implantation of an avantage cemented shell ø48mm, avantage inlay s48, optipac-s 60 refobacin bone cement, femoral stem 12/14 and femoral head sterile 12/14 on (b)(6) 2017. Subsequently, the patient was revised on (b)(6) 2018 due to recurrent dislocations, instability, and impingement. During the revision, a hematoma was noted as well as an absent posterior joint capsule. The avantage cemented shellø48mm was left in place. The stem and femoral head were replaced with a competitor product, and the bearing was replaced by the avantage inlay s48 / 28.

 
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Brand NameOPTIPAC-S 60 REFOBACIN BONE CEMENT R
Type of DeviceBONE CEMENT, ANTIBIOTIC
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 Key8951348
MDR Text Key156780770
Report Number3006946279-2019-00383
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeDA
PMA/PMN NumberK150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number4711500396-1
Device LOT NumberA710B05615
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/19/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/30/2019 Patient Sequence Number: 1
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