MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMORAL WEDGE POSTERIOR SIZE 3/10MM

Catalog Number	02.07.310FPW
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 11 february 2019: lot 140518: (b)(4) items manufactured and released on 27-may-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 other similar reported event.On the 29 january 2019 the device were checked and we detected a packaging lacking, the brach returned only the implant without the packaging.From the returned device no visual inspection is possible because the packaging (that is the subject of this complaint) is lacking.
Event or Problem Description
Femoral wedge posterior was loose in the box, the primary packaging was broken.

• Brand Name: GMK-REVISION FEMORAL WEDGE POSTERIOR SIZE 3/10MM
• Common Device Name: FEMORAL WEDGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8335137
• Report Number: 3005180920-2019-00051
• Device Sequence Number: 206466
• Product Code: JWH
• UDI-Device Identifier: 07630030822179
• UDI-Public: 07630030822179
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 02.07.310FPW
• Device Lot Number: 140518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/13/2019
• 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: Other
• Patient Age: 60 YR
• Patient Weight: 95