MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID SMS SOLID STEM STD SIZE 11; HIP STEM CEMENTLESS

Model Number	01.36.051
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in few days after the primary surgery reporting instability due to a leg length discrepancy and the cause of the leg length discrepancy is unknown.The surgeon revised the stem, head, and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 22.Dec.2021.Lot 2011738: (b)(4) items manufactured and released on 3-feb-2021.Expiration date: 2026-jan-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported event.Additional devices involved.Liner: versafitcup dm 01.26.2852mhc double mobility hc liner ø 52/28 (k092265) lot.2109549: (b)(4) items manufactured and released on 9-sep-2021.Expiration date: 2026-aug-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported event.Ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.2103137: (b)(4) items manufactured and released on 28-jun-2021.Expiration date: 2026-jun-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported event.

• Brand Name: STEM: SMS SOLID SMS SOLID STEM STD SIZE 11
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 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: 13153122
• Report Number: 3005180920-2022-00013
• Device Sequence Number: 4146809
• Product Code: LZO
• UDI-Device Identifier: 07630030888700
• UDI-Public: 07630030888700
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 01/04/2022

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: 01/24/2026
• Device Model Number: 01.36.051
• Device Catalogue Number: 01.36.051
• Device Lot Number: 2011738
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2021
• 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 Sex: Female