MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 3 L

Catalog Number	02.07.2403L
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 04 september 2018.Lot 162074: (b)(4) items manufactured and released on 11 may 2016.Expiration date: 2021-04-11.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.Inspection performed by packaging and washing manager on 07 september 2018: from the pictures an important deformation is evident in the primary and secondary blister.These deformations can be replied putting the packaging near an high temperature heat source or crushing the device under an elevated load.Considering that the box doesn't present damages it is likely that the blister was overheated.We had already similar situation on spine blisters we've analyzed all the medacta production process and we didn't discovered activities leading to a such as deformation.I conclude saying that the product didn't leave medacta with this deformation, but it was caused during the transportation/storage activities.
Event or Problem Description
Upon opening the inner packaging it was noticed that it was compromised and was not deemed to be sterile.An alternative implant that was available has been used.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 3 L
• Common Device Name: FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7854962
• Report Number: 3005180920-2018-00668
• Device Sequence Number: 1272143
• Product Code: JWH
• UDI-Device Identifier: 07630030821400
• UDI-Public: 07630030821400
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/07/2018

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: 04/11/2021
• Device Catalogue Number: 02.07.2403L
• Device Lot Number: 162074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/07/2018
• 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: Other
• Patient Age: 67 YR
• Patient Weight: 120