MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY UC INSERT; FIXED PE TIBIAL INSERT

Catalog Number	02.07.0412FUC
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis from patient matched department made on (b)(6) 2017: extra-analysis: no extra-analysis is possible, since we have not received any x-ray.Conclusions: our analysis of the process of this case found no deviations from the standard procedures.Each step has been performed correctly.Batch review performed on 02 january 2018: (b)(4).Preliminary investigation based on the pictures of the explanted tibia insert, made by r and d project manager on 03 jan 2018: a deep dent can be seen on the articular surface of the insert that looks there damaged.It has not been specified if this dent was caused during explantation or due to the presence of a third body in the joint.No further comments can be done looking at the pictures sent.
Event or Problem Description
The patient came in complaining of instability.The surgeon revised the insert from a 12 mm to a 17 mm.The surgery was completed successfully.

• Brand Name: GMK PRIMARY UC INSERT
• Common Device Name: FIXED PE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7160297
• Report Number: 3005180920-2017-00803
• Device Sequence Number: 19279181
• Product Code: JWH
• UDI-Device Identifier: 07630030817717
• UDI-Public: 07630030817717
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2018

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: 06/30/2020
• Device Catalogue Number: 02.07.0412FUC
• Device Lot Number: 148610
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 01/03/2018
• 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: 71 YR