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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET SPAIN, S.L. PSO KNEE BONE SUBSTITUTION KNEE PROSTHESIS

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BIOMET SPAIN, S.L. PSO KNEE BONE SUBSTITUTION KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Naturally Worn (2988)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: medical product: ref. (b)(4); lot 2007110362; description: tibial revision comp. 72mm -l. Event occurred in (b)(6). This product is manufactured by biomet (b)(6) orthopaedics, (b)(6) and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet (b)(6) manufactures a similar device that is cleared or distributed in the united states under 510(k) numbers: k945028 and k974558. The manufacturing site has changed. Event previously submitted through medwatch (b)(4). Remains implanted.
 
Event Description
It was reported by the pmi group that a patient underwent a left knee arthroplasty on an unknown date. Subsequently, the patient is being considered for a pmi product on (b)(6) 2022 as he has instability by the fracture of the large tibial insert w/screws. Mesta tibial 12 mm grande c/tornillos (rodilla pso/pso knee).
 
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Brand NamePSO KNEE BONE SUBSTITUTION
Type of DeviceKNEE PROSTHESIS
Manufacturer (Section D)
BIOMET SPAIN, S.L.
calle islas baleares, #50
p.o. box 96
fuente del jarro, valencia 46988
SP 46988
Manufacturer (Section G)
BIOMET SPAIN, S.L.
calle islas baleares, #50
p.o. box 96
fuente del jarro, valencia 46988
SP 46988
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key14186868
MDR Text Key289872846
Report Number0009610576-2022-00003
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation
Type of Report Initial
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2011
Device Model NumberN/A
Device Catalogue Number1522-14
Device Lot Number2006110240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/27/2006
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: 04/22/2022 Patient Sequence Number: 1
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