MAUDE Adverse Event Report: AAP BIOMATERIALS GMBH SIMPLEX HV WITH GENTAMICIN

Model Number 6195-1-001

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Missing Value Reason (3192)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 05/17/2016

Event Type  Injury  

Manufacturer Narrative

Device not available for evaluation.

Event Description

Patient had a stryker knee and is currently experiencing pain, muscle spasms and swelling.Patient had procedure at (b)(6) clinic by dr.(b)(6).Update as per patient: right knee.

• Brand Name: SIMPLEX HV WITH GENTAMICIN
• Type of Device: SIMPLEX HV WITH GENTAMICIN
• Manufacturer (Section D): AAP BIOMATERIALS GMBH; lagerstrasse 11-15; dieburg, 64807 ; GM 64807
• Manufacturer (Section G): AAP BIOMATERIALS GMBH; lagerstrasse 11-15; dieburg, 64807 ; GM 64807
• Manufacturer Contact: volker stirnal ; lagerstrasse 11-15; dieburg, 64807 ; GM 64807 ; 9607192922
• MDR Report Key: 6313769
• MDR Text Key: 66871939
• Report Number: 9615014-2017-00013
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Patient
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2015
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-010
• Device Lot Number: 329BA878EU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TRI CEMENTED STEM 12MMX100MM (5560-S-201); TRI PRESS-FIT STEM 16MM X 100MM (5565-S-016); TRI TS BASEPLATE SIZE 5 (5521-B-500); TRI TS FEMUR SZ5 RIGHT (5512-F-502); TRIATHLON ASYMMETRIC X3 PATELLA (5551-G-401); TRIATHLON FEMORAL DISTAL AUGMENT 5MM - SIZE 5 RIGH; TRIATHLON PS X3 TIBIAL INSERT (5532-G-513); UNKNOWN_RECONSTRUC TIVE_PRODUCT
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 84