MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-P QUADRA-P CEMENTED STD STEM SIZE 2; HIP CEMENTED STEM

Model Number	01.12.212
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16-dec-2020: lot 1908196: (b)(4) items manufactured and released on 11-feb-2020.Expiration date: 2025-jan-25.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold without any other similar reported event.Other devices involved in the event: ball heads: mectacer 01.29.213 biolox delta ceramic ball head 12/14 ø 40 size m 0 lot.183367 (k112115), batch review performed on 16-dec-2020: lot 183367: (b)(4) items manufactured and released on 23-jul-2018.Expiration date: 2023-jul-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Liner: mpact 01.32.4052hct flat pe hc liner ø40/g lot.180655 (k122641) batch review performed on 16-dec-2020.Lot 180655: (b)(4) items manufactured and released on 28-may-2018.Expiration date: 2023-may-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting pain due to a dislocation of the head from the liner about 2 months after the primary surgery.The surgeon decided to perform a closed reduction on the patient to resolve the dislocation.During the closed reduction, the quadra p stem dissociated from the cemented mantle.The surgeon decided to revise the patient's stem, head, and liner.The surgery was complete successfully.

• Brand Name: STEM: QUADRA-P QUADRA-P CEMENTED STD STEM SIZE 2
• Common Device Name: HIP CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11030102
• Report Number: 3005180920-2020-00926
• Device Sequence Number: 1307520
• Product Code: LZO
• UDI-Device Identifier: 07630040732093
• UDI-Public: 07630040732093
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2025
• Device Model Number: 01.12.212
• Device Catalogue Number: 01.12.212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2020
• Initial Report FDA Received Date: 12/17/2020
• 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