MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED PS SIZE 4 NARROW / LEFT; KNEE FEMORAL COMPONENT CEMENTED

Catalog Number	02.07.2214L
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2017.Lot 132520: (b)(4) items manufactured and released on 03 june 2013.Expiration date: 2018-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.On (b)(6) 2017 the r&d project manager performed a preliminary investigation based on the event description and on the available pictures (of the revision surgery and of explanted component) and commented as follows: revision surgery after 3 years from primary implantation due to loosening of the femoral component.The explanted femoral components doesn't present any anomalies, and it seems to be in compliance with the specifications required.It doesn't present any residual cement on its inner part.It is something usual to be seen on the explanted component, since the cement is a filler and not an adhesive.All the residual cement tends to remain grabbed on the bone.The same considerations can be extended to the explanted tibia component.No further considerations can be done based on the picture enclosed.On (b)(6) 2017 the medical affairs director performed a clinical evaluation and commented as follows: revision of primary cemented tka after 3.5 years, due to femoral component loosening.We have no details of potential problems that may have arisen during operation.It is conceivable that a cementation problem may have contributed to this loosening, but there is no information to substantiate this hypothesis.The gap between the anterior flange and the femoral cortex, and the cement demarcation line, are aspects that witness the loosening, but they cannot be determined to be the cause.There is however no reason to suspect a faulty device.
Event or Problem Description
The patient came in complaining of pain.The surgeon determined the femur was loose.The surgeon revised the femur, tibia and insert.The surgery was completed successfully.X-rays are available.Explants are not available.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED PS SIZE 4 NARROW / LEFT
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6847608
• Report Number: 3005180920-2017-00496
• Device Sequence Number: 18848280
• Product Code: JWH
• UDI-Device Identifier: 07630030820984
• UDI-Public: 07630030820984
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 02.07.2214L
• Device Lot Number: 132520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention