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

Catalog Number	01.18.136
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Disorder (2373)
Date of Event	10/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second revision surgery underwent by the patient.The patient had a primary hip in (b)(6) 2017.In (b)(6) l 2017 the surgeon revised the patient due to an infection (pathogen confirmed as e.Coli).The surgeon washed out the patient and revised the head and liner.Then, in (b)(6) 2017 the patient fell and came in complaining of pain.On(b)(6) 2017 the medical affairs director performed a clinical evaluation and commented as follows: six months after revision surgery, total hip re-revision is required.Radiographic image shows the presence of a mobilized cup caused by a traumatic event.The initial position of the cup cannot be assessed having only one post-traumatic x-rays.On the basis of available data, there is no reason to suspect a faulty device.Batch reviews performed on 13 november 2017.Lot 164614: (b)(4) items manufactured and released on 09 november 2016.Expiration date: 2021-10-30.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 l +3.5, code 01.29.203, lot.163448 (k112115) (b)(4) items manufactured and released on 28 october 2016.Expiration date: 2021-09-21.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 the lot.Versafitcup acetabular shell ø 52, code 01.26.52mb, lot.161582 (k083116) (b)(4) items manufactured and released on 09 november 2016.Expiration date: 2021-10-30.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 52/28, code 01.26.2852mhc, lot.162321 (k092265) (b)(4) items manufactured and released on 25 july 2016.Expiration date: 2021-06-29.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 the lot.
Event or Problem Description
The patient fell and came in complaining of pain.The surgeon determined the cup was knocked loose with the fall.The surgeon also determined that the patient was infected.The pathogen is unknown.The surgeon revised all medacta hardware.The surgery was completed successfully.

• Brand Name: AMISTEM H, HA COATED STEM 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: 7032793
• Report Number: 3005180920-2017-00659
• Device Sequence Number: 13872280
• Product Code: LZO
• UDI-Device Identifier: 07630030804120
• UDI-Public: 07630030804120
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

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: 10/30/2021
• Device Catalogue Number: 01.18.136
• Device Lot Number: 164614
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/15/2017
• 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: 65 YR