MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 5; HIP STEM CEMENTLESS

Model Number	01.18.135
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 years after the primary surgery, the patient came in for a hip revision and the cause is unknown.The surgeon revised the stem and head with competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully.It is probably that the patient came reporting pain.
Additional Manufacturer Narrative
Batch review performed on 20-dec-2022: lot 145415: (b)(4) items manufactured and released on 13-oct-2014.Expiration date: 2019-08-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported case during the period of review.Additional components involved: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115).Lot 152601: (b)(4) items manufactured and released on 13-oct-2015.Expiration date: 2020-09-30.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported case during the period of review.Liner: versafitcup dm 01.26.2848mhc double mobility hc liner ø 48/28 (k092265) lot 153654: (b)(4) items manufactured and released on 01-oct-2015.Expiration date: 2020-08-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 5
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16061011
• Report Number: 3005180920-2022-00986
• Device Sequence Number: 16652540
• Product Code: LZO
• UDI-Device Identifier: 07630030804113
• UDI-Public: 07630030804113
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2022

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: 08/31/2019
• Device Model Number: 01.18.135
• Device Catalogue Number: 01.18.135
• Device Lot Number: 145415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2014
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female