MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-C CEMENTED, MIRROR POLISHING STEM SIZE 0 STD 12/14; CEMENTED FEMORAL STEM

Catalog Number	01.12.040
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 26 june 2017.Lot 102745: (b)(4)items manufactured and released on 15 september 2010.Expiration date: 2020-05-31.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.Not yet received,.
Event or Problem Description
When opening the packaging of the implant, the stem had pierced both blisters, inner and outer one.Only the white external packaging was not damaged.The stem wasn't implantable.
Additional Manufacturer Narrative
On 18 july 2017 the packaging and washing manager performed a visual inspection of the retrieved item and commented as follows: considering the implant that was not in a correct position, it is probable that during the transportation or implant storage the distal foam slightly disassembled from the implant and the plastic packaging, inner and outer, was broken due to the nature of the stem and because it was free to move.The displacement possibly occurred due to forces experienced during transportation.The packaging configuration allow more degrees of freedom for movement within the package.The carton box is broken as well in the middle part, sign of different forces possibly experienced during transportation.

• Brand Name: QUADRA-C CEMENTED, MIRROR POLISHING STEM SIZE 0 STD 12/14
• Common Device Name: CEMENTED FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6672561
• Report Number: 3005180920-2017-00345
• Device Sequence Number: 11233389
• Product Code: LZO
• UDI-Device Identifier: 07630030802218
• UDI-Public: 07630030802218
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083558
• 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,Followup
• Report Date (Section B): 07/27/2017

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: 05/31/2020
• Device Catalogue Number: 01.12.040
• Device Lot Number: 102745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2017
• Supplement Date Received by Manufacturer: 05/29/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 07/27/2017
• 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