MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TIBIAL INSERT; FIXED TIBIAL INSERT SIZE 1 / 10 MM RIGHT

Catalog Number	02.12.0110FR
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 july 2017.Lot 142847: (b)(4) items manufactured and released on 06 june 2014.Expiration date: 2019-04-30.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 28 july 2017 the medical affairs director checked the x-ray commenting as following: 7 months after primary tkr the insert fixation screw got loose in the joint.It was immediately removed with an arthroscopic operation.No consequence should be expected for the absence of the screw in the future life of the implant.According to report, there is minimum damage to the femoral component surface, in an area of marginal or negligible bearing, therefore little or no further consequence should be expected from this event.The cause for self-unscrewing of the insert screw is not known: one possibility is insufficient tightening torque, but other unknown conditions may also play a role.
Event or Problem Description
During routine follow-up 8 months after primary, the study assistant noticed on the patients x-ray that the screw in the insert appeared to be in the incorrect position.The x-ray was sent to medacta international for examination by a knee bioengineer who confirmed (on (b)(6) 2017) that the screw was not fixed and whilst the screw had not migrated out completely was definitely migrating out.The advice given was to inform the surgeon and remove the screw as soon as possible before damage to articulating surfaces can occur.The patient presented at emergency department on (b)(6) with pain in her knee and was sent to surgery when, on x-ray, it was noticed the screw was sitting in the lateral pocket of the knee.The surgeon, using scope, removed the screw and identified small scratches on, what appears to be, a non articulating part of the femoral implant.
Additional Manufacturer Narrative
On 08 september 2017 the r&d project manager performed a visual inspection of the explanted insert fixation screw and commented as follows: loosened insert safety screw occurred eight months after primary surgery removed by arthroscopy.The threaded part and the screw looks damaged.The screw has been plastically deformed once, backed out from the baseplate, was interposed between the femoral component and the tibia insert and underwent to the body load.No other components have been explanted.The most-likely cause for self-unscrewing of the screw after few months from implantation, was insufficient tightening torque.Using a screwdriver provided with a torque limitation would prevent this event.Torque limiter screwdriver is already available and its use is mandatory.

• Brand Name: GMK SPHERE TIBIAL INSERT
• Common Device Name: FIXED TIBIAL INSERT SIZE 1 / 10 MM RIGHT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6760053
• Report Number: 3005180920-2017-00423
• Device Sequence Number: 1571166
• Product Code: JWH
• UDI-Device Identifier: 07630030825941
• UDI-Public: 07630030825941
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2017

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: 04/30/2019
• Device Catalogue Number: 02.12.0110FR
• Device Lot Number: 142847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 09/13/2017
• 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
• Patient Age: 62 YR