MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZ 3 LEFT

Catalog Number	02.12.0003L
Health Effect - Clinical Code	Joint Disorder (2373)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second revision surgery underwent by the patient.She had a primary surgery on (b)(6) 2016.The patient was revised the first time on (b)(6) 2017 as the patient lacked flexion.The surgeon removed the cemented patella as well as 3-4mm of bone, 120 days after primary.The surgeon implanted a size 3 patella and performed a lateral release to ease soft tissue tension.The surgery was completed successfully.Then, the patient underwent the subject revision surgery.On (b)(6) 2017 the patient match department provided a planning review of this case, reporting as follows: our analysis of the planning process of this case found no deviations from the standard procedures.Each step has been performed correctly.Batch review performed on (b)(6) 2017.Lot 162327: (b)(4) items manufactured and released on (b)(6) 2016.Expiration date: 2021-09-27.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 13 october 2017 the medical affairs director performed a clinical evaluation and commented as follows: revision surgery of primary cemented tka implanted (b)(6) took place twice: the first time a correction of patellar resurfacing and ligament release were performed (not object of this complaint); the second time required explant of femoral component and repositioning.From the x-ray supplied, the femoral component appears in fact to be malrotated (we cannot determine if it was internally or externally rotated) and therefore flexion and patella tracking could be compromised.The problem seems to have been originated by a technical problem during first surgery, origin unknown, and we see no evidence that it could be related to a faulty device.
Event or Problem Description
The patient underwent an additional surgery on (b)(6) 2017 because the femur was malrotated.The surgeon revised the femoral component and the insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZ 3 LEFT
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6947958
• Report Number: 3005180920-2017-00585
• Device Sequence Number: 505899
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2017

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: 09/27/2021
• Device Catalogue Number: 02.12.0003L
• Device Lot Number: 165037
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/13/2017
• 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