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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET SPAIN, S.L. PERFORMANCE TOTAL KNEE PROSTHESIS; PROSTHESIS, KNEE
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BIOMET SPAIN, S.L. PERFORMANCE TOTAL KNEE PROSTHESIS; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Naturally Worn (2988); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 05/09/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Medical product: tibial tray ref 141233; lot 311360.Inlay ref.179370; lot 482710.Report source: event occurred in (b)(6).Pma/510k:this device is not manufactured by zimmer biomet in the united states; however, we are filing this report as zimmer biomet manufactures a similar device in the united states under 510k number k023546.Product not returned yet.
 
Event Description
It was reported a patient had a rtka in (b)(6) 2007.In (b)(6) 2018, an ask (arthroscopy) of the knee was diagnosed with a low grade infection.In the further course a puncture and an ask of the knee joint were carried out without proof of infection but with clear indications of an inlay abrasion as well as inlay abort.After appropriate preoperative preparation on (b)(6) 2019, the knee was revised without complication.
 
Manufacturer Narrative
(b)(4).D10: attached (b)(4) product analysis report.D11: medical product.Tibial tray ref 141233; lot 311360.Inlay ref.179370; lot 482710.G3: event ocurred in germany.G5:this device is not manufactured by zimmer biomet in the united states; however, we are filing this report as zimmer biomet manufactures a similar device in the united states under 510k number k023546.
 
Event Description
It was reported a patient had a rtka in (b)(6) 2007.In (b)(6) 2018, an ask (arthroscopy) of the knee was diagnosed with a low grade infection.In the further course a puncture and an ask of the knee joint were carried out without proof of infection but with clear indications of an inlay abrasion as well as inlay abort.After appropriate preoperative preparation on (b)(6) 2019, the knee was revised without complication.
 
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Brand Name
PERFORMANCE TOTAL KNEE PROSTHESIS
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET SPAIN, S.L.
calle islas baleares, #50
p.o. box 96
fuente del jarro, valencia 46988
SP  46988
MDR Report Key9238057
MDR Text Key173445732
Report Number0009610576-2019-00015
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/01/2014
Device Model NumberN/A
Device Catalogue Number7504-07-074
Device Lot Number2006080511
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2019
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received09/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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