MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø32/C; HIP SHELL INSERT

Catalog Number	01.32.3239HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02.Sep.2019: lot 1810215: (b)(4) items manufactured and released on 10-dec-2018.Expiration date: 2023-11-27.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.Additional device involved- batch review performed on 02.Sep.2019: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115), lot 187076: (b)(4) items manufactured and released on 15-jan-2019.Expiration date: 2023-12-16.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 due to signs of infection after about 2 months from primary, the pathogen is unknown.The surgeon performed an i&d and revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/C
• Common Device Name: HIP SHELL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9075826
• Report Number: 3005180920-2019-00780
• Device Sequence Number: 2928601
• Product Code: LPH
• UDI-Device Identifier: 07630030811845
• UDI-Public: 07630030811845
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2019

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: 11/27/2023
• Device Catalogue Number: 01.32.3239HCT
• Device Lot Number: 1810215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/17/2019
• 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: 59 YR