MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER 32 / E; ACETABULAR PE HC LINER

Model Number	01.26.3244HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 8 april 2020: lot 134666: (b)(4) items manufactured and released on 15-nov-2013.Expiration date: 2018-10-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2016.Additional implant involved: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.165968.Batch review performed by medacta regulatory affairs department on 8 april 2020: lot 165968: (b)(4) items manufactured and released on 11-jan-2017.Expiration date: 2021-12-20.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.Clinical evaluation performed by medical affairs director: 2,5 years after primary cementless tha a dislocation occurs and requires revision of the acetabular implant.In the radiograph supplied, this patients presents a multi-level lumbar arthrodesis, which is very likely to have contributed to the dislocation.We do not know if this stabilization was executed before or after the tha, but the relationship is very likely to be relevant.No reason to suspect a faulty device.
Event or Problem Description
The patient came in reporting pain due to a dislocation of the head from the liner 2 years and 5 months after the primary.The cause of the dislocation is unknown.The surgeon revised the cup, liner, and head and the surgery was completed successfully.
Additional Manufacturer Narrative
On february 04th 2021 we have received the following details related to the patient: patient date of birth: (b)(6) 1953.Weight: 210 lb.Race: white.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER 32 / E
• Common Device Name: ACETABULAR PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10008491
• Report Number: 3005180920-2020-00262
• Device Sequence Number: 2897065
• Product Code: LZO
• UDI-Device Identifier: 07630030807572
• UDI-Public: 07630030807572
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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: 10/31/2018
• Device Model Number: 01.26.3244HCT
• Device Catalogue Number: 01.26.3244HCT
• Device Lot Number: 134666
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 03/03/2021
• 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: 66 YR
• Patient Weight: 95