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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 No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: axle 30 mm pso knee ref. 1520-34, lot 2008091292. Circlip pso knee ref. 1520-22, lot 2009070978. Straight stem 12x250mm ref. 1528-33, lot 03081325. Straight stem ref. 1528-60, lot 2008011263. Femoral primary component 64mm left med. Ref. 1521-11, lot 02093477. Pma/510k #: this product is manufactured by biomet (b)(4) orthopaedics, (b)(4) and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet (b)(4) 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 # 0001825034-2019-02313. Device evaluated by mfr: remains implanted.
 
Event Description
It was reported that the patient had an initial left knee arthroplasty on unknown date in (b)(6) 2010. Subsequently, the pmi group is requesting a custom implant to revise the pso prosthesis on (b)(6) 2019 due polyethylene wear. The revision surgery is planned for the end of (b)(6) or (b)(6).
 
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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 Key8801638
MDR Text Key151428461
Report Number0009610576-2019-00012
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 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2013
Device Model NumberN/A
Device Catalogue Number1521-03
Device Lot Number2008041370
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 Received04/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/18/2019 Patient Sequence Number: 1
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