MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STEM SIZE 8 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.12.028
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 31 october 2017 the cleaning and packaging manager performed a visual inspection of the retrieved item and commented as follows: the returned packaging was analysed and it is confirmed that the packaging is scratched and the tip of the stem is out of the white mousse.This evidently occurred due to forces experienced during transportation.This is indicated to be correlated to the combination of the packaging configuration applied and the shorter length stems as they allow more degrees of freedom for movement within the package.Batch review performed on 13 november 2017.Lot 164549: (b)(4) items manufactured and released on 24 october 2016.Expiration date: 2021-10-06.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.
Event or Problem Description
The stem was loose in the pack.The pack has a damage because of the impingement with the stem.A second implant was used to complete the surgery.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STEM SIZE 8 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7040115
• Report Number: 3005180920-2017-00675
• Device Sequence Number: 1469601
• Product Code: LZO
• UDI-Device Identifier: 07630030802096
• UDI-Public: 07630030802096
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: 10/06/2021
• Device Catalogue Number: 01.12.028
• Device Lot Number: 164549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/17/2017
• 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: Other