MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED HA COATED STEM SIZE 1 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.231
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 18 september 2017.Lot 155245: (b)(4) items manufactured and released on 15 january 2016.Expiration date: 2021-01-02.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 cc trio ø 46, code 01.26.45.0046, lot.160097 (k103352) (b)(4) items manufactured and released on 29 april 2016.Expiration date: 2021-04-13.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 flat pe hc liner ø 32 / c, code 01.26.3239hct, lot.160851 (k120531) (b)(4) items manufactured and released on 19 may 2016.Expiration date: 2021-05-01.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 32 size s -4, code 01.29.204, lot.160547 (k112115) (b)(4) items manufactured and released on 29 april 2016.Expiration date: 2021-04-14.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.Cancellous bone screw flat head ø 6,5 l 25, code 01.26.65.25, lot.154186 (k103352) (b)(4) items manufactured and released on 06 october 2015.Expiration date: 2020-08-31.No anomalies found related to the reported issue.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on this lot.
Event or Problem Description
The patient came in due to signs of infection.The patient was positive for an infection.The pathogen will not be disclosed.The surgeon removed all medacta hardware and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
On 01 december 2017 we were informed by the complainer that the second step of the surgery has been completed.The surgeon revised the abx spacer and implanted permanent product.The surgery was completed successfully on (b)(6) 2017.
Event or Problem Description
The patient came in due to signs of infection.The patient was positive for an infection.The pathogen will not be disclosed.The surgeon removed all medacta hardware and implanted an antibiotic spacer.The surgery was completed successfully.On 01 december 2017 we were informed by the complainer that the second step of the surgery has been completed.The surgeon revised the abx spacer and implanted permanent product.The surgery was completed successfully on (b)(6) 2017.

• Brand Name: AMISTEM COLLARED HA COATED STEM SIZE 1 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6878304
• Report Number: 3005180920-2017-00529
• Device Sequence Number: 16264398
• Product Code: LZO
• UDI-Device Identifier: 07630030804564
• UDI-Public: 07630030804564
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

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: 01/02/2021
• Device Catalogue Number: 01.18.231
• Device Lot Number: 155245
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 12/29/2017
• 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: 50 YR