MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM COLLARED HA COATED STD STEM SIZE 00; CEMENTLESS HIP STEM

Catalog Number	01.18.229
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 september 2018 lot 152554: (b)(4) items manufactured and released on 05 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.Others devices involved: mectacer reference 01.29.203 (k112115) biolox delta ceramic ball head 12/14 ø 28 size l +3.5 lot 151722: (b)(4) items manufactured and released on 05 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 dm 01.26.2850mhc (k092265) double mobility hc liner ø 50/28 lot 154206: (b)(4) items manufactured and released on 22 october 2015.Expiration date: 2020-10-07 no anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 7 months after primary the surgeon revised the patient for hip generic pain.The reason of pain in unknown.The surgery was completed successfully.

• Brand Name: STEM COLLARED HA COATED STD STEM SIZE 00
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7845329
• Report Number: 3005180920-2018-00655
• Device Sequence Number: 16659596
• Product Code: LZO
• UDI-Device Identifier: 07630030804540
• UDI-Public: 07630030804540
• Combination Product (Y/N): N
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: 06/30/2020
• Device Catalogue Number: 01.18.229
• Device Lot Number: 152554
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 09/05/2018
• 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