MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / F

Catalog Number	01.26.3648HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 7 january 2020: lot 179315: (b)(4) items manufactured and released on 11-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.Additional implants involved in the event, batch review performed on 7 january 2020: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.179000.Lot 179000: (b)(4) items manufactured and released on 3-may-2018.Expiration date: 2023-04-22.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.Stem: quadra-h 01.12.028 cementless, ha coated std stem size 8 (k082792) lot.185959 lot 185959: 32 items manufactured and released on 11-dic-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 similar reported event.Cup: versafitcup cc trio 01.26.45.1160 acetabular shell cc trio no-hole ø 60 (k122911) lot.121904a.Lot 121904a: (b)(4) items manufactured and released on 9-apr-2018.Expiration date: 2023-03-25.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.
Event or Problem Description
Revision of all hip components, 8 months after primary surgery, due to streptococcosis infection.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager: delayed infection in cementless tha, 8 months after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / F
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9568608
• Report Number: 3005180920-2019-01128
• Device Sequence Number: 16978548
• Product Code: LZO
• UDI-Device Identifier: 07630030807688
• UDI-Public: 07630030807688
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• 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,Followup
• Report Date (Section B): 01/09/2020

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: Health Professional
• Device Expiration Date: 03/26/2023
• Device Catalogue Number: 01.26.3648HCT
• Device Lot Number: 179315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 01/09/2020
• 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: 68 YR