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

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).

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/psoknee).

Manufacturer Narrative

(b)(4).D10: medical product, ref.1521-05; lot 2007110362; description: tibial revision comp.72mm -l- g2: event occurred in spain.G5: this product is manufactured by biomet spain orthopaedics, s.L.And is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet warsaw manufactures a similar device that is cleared or distributed in the united states under 510(k) number k945028 and k974558.The manufacturing site has changed.Event previously submitted through medwatch 0001822565-2022-00788.H3 other text : remains implanted.

• Brand Name: PSO KNEE BONE SUBSTITUTION
• Type of Device: KNEE PROTHESIS
• 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 Key: 14186868
• MDR Text Key: 289872846
• Report Number: 0009610576-2022-00003
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2011
• Device Model Number: N/A
• Device Catalogue Number: 1522-14
• Device Lot Number: 006110240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male