MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 4; CEMENTLESS STEM

Model Number	01.18.144
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 april 2022.Lot 131562: (b)(4) items manufactured and released on 22-jul-2013.Expiration date: 2018-aug-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Visual inspection performed by r&d project manager.During the analysis it is evaluated that around proximal half of the stem body is covered with ha coating.This means that the stem was not correctly osseointegrated with the patient's bone.Some residuals of bone fragments are present on the stem body microstructures.Additionally, some signs and scratches together with burns are present on the stem body probably due to revision surgery.Regarding the liner, no particular signs related to the event were noticed.It is not possible to determine the root cause from the received information.Additional item involved in the event, batch review performed on 14 april 2022: liner: versafitcup dm 01.26.2856mhc double mobility hc liner ø 56/28 (k092265) lot.131722 lot 131722: (b)(4) items manufactured and released on 06-jun-2013.Expiration date: 2018-aug-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Ball heads: cocr 01.25.013 cocr ball head 12/14 ø 28 size l +3.5 (k072857) lot.130913.Lot 130913: (b)(4) items manufactured and released on 23-may-2013.Expiration date: 2018-apr-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Event or Problem Description
Unchanged pain.Especially during exertion, after walking 200 m, pain in the left hip occurs.The pain is oriented anterolaterally.Pain at night or at rest is less predominant.Revision surgery performed 8 years and 6 months after the primary.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 4
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14369186
• Report Number: 3005180920-2022-00361
• Device Sequence Number: 5769938
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

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: 08/31/2018
• Device Model Number: 01.18.144
• Device Catalogue Number: 01.18.144
• Device Lot Number: 131562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 77 YR
• Patient Sex: Male