MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C, CEMENTED STEM SIZE 0 STD; CEMENTED FEMORAL STEM

Catalog Number	01.18.150
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Disorder (2373)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 11 september 2017.Lot 155215: (b)(4) items manufactured and released on 23 september 2015.Expiration date: 2020-09-09.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.Mpact acetabular shell ø54 multi-hole, code 01.32.154mh, lot.133724 (k132879) (b)(4) items manufactured and released on 03 february 2014.Expiration date: 2018-12-31.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.Mpact flat pe hc liner ø36/e, code 01.32.3644hct, lot.153133 (k103721) (b)(4) items manufactured and released on 08 october 2015.Expiration date: 2020-09-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on this lot.Mectacer biolox delta ceramic ball head 12/14 ø 36 size m 0, code 01.29.209, lot.151164 (k112115) (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.Mpact cancellous bone screw, flat head ø 6,5 l 30, code 01.32.6530, lot.130452 (k103721) (b)(4) items manufactured and released on 13 march 2013.Expiration date: 2018-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on items of the same lot.Mpact cancellous bone screw, flat head ø 6,5 l 20, code 01.32.6520, lot.150699 (k103721) (b)(4) items manufactured and released on 26 may 2015.Expiration date: 2020-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on this lot.Mpact cancellous bone screw, flat head ø 6,5 l 30, code 01.32.6530, lot.145878 (k103721) (b)(4) items manufactured and released on 13 january 2015.Expiration date: 2019-10-31.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.Mpact cancellous bone screw, flat head ø 6,5 l 35, code 01.32.6535, lot.115666 (k103721) (b)(4) items manufactured and released on 20 april 2012.Expiration date: 2017-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and this is the third similar event reported on items of this lot (complaint (b)(4)).
Event or Problem Description
The patient came in complaining of instability.The surgeon determined the stem was loose.The patient was also infected.The infection is not believed to have caused the loosening.The pathogen is unknown.The surgeon revised all medacta product.The surgeon plans to implant a spacer at a later date.The surgery was completed successfully.

• Brand Name: AMISTEM C, CEMENTED STEM SIZE 0 STD
• Common Device Name: CEMENTED FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6860918
• Report Number: 3005180920-2017-00512
• Device Sequence Number: 10926801
• Product Code: LZO
• UDI-Device Identifier: 07630030804250
• UDI-Public: 07630030804250
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

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: 09/09/2020
• Device Catalogue Number: 01.18.150
• Device Lot Number: 155215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/13/2017
• 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: 57 YR