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

Catalog Number	01.12.122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	04/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 april 2024: lot 2339148: (b)(4) items manufactured and released on 05-dec-2023.Expiration date: 2028-nov-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by clinical affairs department: revision 4 days after the primary tha surgery due to the increased postoperative length of the leg.This is not a defect the product implanted but a technical error during surgery.Additional details, batch review performed on 26 april 2024: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.2340135 lot 2340135: (b)(4) items manufactured and released on 02-nov-2023.Expiration date: 2028-oct-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Liner: cc e cc light 01.26.3239hct flat pe hc liner ø 32 / c (k120531) lot.2303230 lot 2303230: (b)(4) items manufactured and released on 17-apr-2023.Expiration date: 2028-mar-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Cup: versafitcup cc trio 01.26.45.1146 acetabular shell cc trio no-hole ø46 (k122911) lot.2216281 lot 2216281: (b)(4) items manufactured and released on 05-oct-2022.Expiration date: 2027-sep-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Revision surgery performed 4 days after the primary surgery due to the increased postoperative length of the leg.A smaller sized cemented stem has been implanted with a double mobility system.

• Brand Name: STEM: QUADRA-P QUADRA-P STD STEM SIZE 2
• Common Device Name: HIP CEMENTLESS STEM
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19339180
• Report Number: 3005180920-2024-00323
• Device Sequence Number: 18316253
• Product Code: LZO
• UDI-Device Identifier: 07630040720434
• UDI-Public: 07630040720434
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K181254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/17/2024

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 Catalogue Number: 01.12.122
• Device Lot Number: 2339148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2023
• 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: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White