MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED STEM, HA COATED SIZE 6 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.236
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 25 august 2017 the medical affairs performed a clinical evaluation and commented as follows: late infection in cementless tha, 2 years after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Batch reviews performed on 04 september 2017.Lot 146198: (b)(4) items manufactured and released on 13 january 2015.Expiration date: 2019-11-30.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.Mectacer biolox delta ceramic ball head 12/14 ø 28 size s -3.5, code 01.29.201, lot.151720 (k112115) (b)(4) items manufactured and released on 29 september 2015.Expiration date: 2020-08-31.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.Versafitcup acetabular shell ø 54, code 01.26.54mb, lot.152020 (k083116) (b)(4) items manufactured and released on 26 august 2015.Expiration date: 2020-06-30.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.Versafitcup double mobility hc liner ø 54/28, code 01.26.2854mhc, lot.152103 (k092265) (b)(4) items manufactured and released on 24 august 2015.Expiration date: 2020-06-30.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 patient came in due to signs of infection (left hip).The pathogen is unknown.The infection caused the stem to become loose.The surgeon revised all medacta hardware and re-implanted permanent product.The surgery was completed successfully.X-rays are available.Explants are not available.

• Brand Name: AMISTEM COLLARED STEM, HA COATED SIZE 6 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6851066
• Report Number: 3005180920-2017-00505
• Device Sequence Number: 1511709
• Product Code: LZO
• UDI-Device Identifier: 07630030804618
• UDI-Public: 07630030804618
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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: 11/30/2019
• Device Catalogue Number: 01.18.236
• Device Lot Number: 146198
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 09/08/2017
• 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: Required Intervention
• Patient Age: 77 YR