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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. GTS STANDARD FEMORAL STEM SIZE -2 PROSTHESIS, HIP

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BIOMET FRANCE S.A.R.L. GTS STANDARD FEMORAL STEM SIZE -2 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
Patient Problems Fall (1848); Failure of Implant (1924)
Event Date 11/02/2013
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products and therapy dates: exceed cup size 50, head ceramic size 28, exceed polyethylene insert size 28. Report source, foreign - event occurred in (b)(6). Device evaluated by mfr? the device was not evaluated as the batch number was not communicated and the product was not returned. The device was not returned to the manufacturer. Therefore it could not be analyzed. The device manufacturing quality record could not be reviewed as lot number of the product was not communicated. With the available information, the exact root cause of the event could not be determined. Please note that the patient fall was mentioned as related to the implant failure in the event description. 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 was reported that a patient underwent an initial hip procedure on (b)(6) 2013. Subsequently, the patient was revised due to femoral implant failure after fall on (b)(6) 2013.

 
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Brand NameGTS STANDARD FEMORAL STEM SIZE -2
Type of DevicePROSTHESIS, 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 Key8353648
MDR Text Key136627126
Report Number3006946279-2019-00131
Device Sequence Number1
Product Code OCG
Combination Product (Y/N)N
PMA/PMN NumberN/A
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 09/03/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue NumberPS129GM2
Device LOT NumberNOT COMMUNICATED
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 Received09/02/2019
Was Device Evaluated By Manufacturer? No
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: 02/20/2019 Patient Sequence Number: 1
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