MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 7; HIP CEMENTLESS STEM

Model Number	01.13.107L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regualtory affairs department on 3 june 2020 lot 170633: (b)(4) items manufactured and released on 20-jun-2017.Expiration date: 2022-06-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other devices involved in the event: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 28 size s -3.5 lot.174686 (k112115) batch review performed by medacta regualtory affairs department on 3 june 2020 lot 174686: (b)(4) items manufactured and released on 5-jan-2018.Expiration date: 2022-12-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Cup: versafitcup cc 01.26.52mb acetabular shell cc 52 lot.178348 (k083116) batch review performed by medacta regualtory affairs department on 3 june 2020: lot 178348: (b)(4) items manufactured and released on 10-apr-2018.Expiration date: 2023-03-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Liner: versafitcup dm 01.26.2852mhc double mobility hc liner 52/28 lot.177528 (k092265) batch review performed by medacta regualtory affairs department on 3 june 2020 lot 177528: (b)(4) items manufactured and released on 20-feb-2018.Expiration date: 2023-03-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 2 similar reported events.
Event or Problem Description
The patient came in 1 year and 1 month after the primary surgery due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised all implants.The surgery was completed successfully.

• Brand Name: STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 7
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10157892
• Report Number: 3005180920-2020-00346
• Device Sequence Number: 19538961
• Product Code: LZO
• UDI-Device Identifier: 07630030803277
• UDI-Public: 07630030803277
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2020

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: No Information
• Device Expiration Date: 06/13/2022
• Device Model Number: 01.13.107L
• Device Catalogue Number: 01.13.107L
• Device Lot Number: 170633
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/16/2020
• 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
• Patient Age: 14 YR