MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER 32/F; ACETABULAR PE HC LINER

Model Number	01.32.3248HCT
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 december 2020: lot 1909324: (b)(4) items manufactured and released on 12-dec-2019.Expiration date: 2024-11-26.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 implant involved: cup: mpact 01.32.156sh acetabular shell ø56 no-hole (k132879) lot.2000215.Batch review performed on 27 november 2020: lot 2000215: (b)(4) items manufactured and released on 06-may-2020.Expiration date: 2025-04-23.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.Visual inspection performed by r&d project manager: visual inspection performed on 16th december 2020.From the received parts, it was not possible to determine with certainty the root cause of the event, but from the surfaces a possible third body presence has not to be excluded.Clinica evaluation performed by medical affairs director: few weeks after primary hybrid tha the patient feels pain at the abdomen and can not bear weight.The cup is revised, osteolysis found cranially to the implant and a cemented cup put in place.Given the very limited time in vivo, the osteolysis could not be originated by the implant.A low-grade infection could be an explanation, but it is not mentioned in the report.If the cause for the removal was poor quality bone, certainly the implant did not play a role in this adverse event.
Event or Problem Description
The patient had pain and could not stand on the leg - through radiological examination, the surgeon saw some osteolysis on the cup.He decided to remove it and to implant a new one, 3 months after primary surgery.Since the bone was not good enough, we had to implant a cemented one.

• Brand Name: LINER: MPACT FLAT PE HC LINER 32/F
• Common Device Name: ACETABULAR PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11027612
• Report Number: 3005180920-2020-00902
• Device Sequence Number: 668605
• Product Code: LPH
• UDI-Device Identifier: 07630030811951
• UDI-Public: 07630030811951
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 12/17/2020

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: 11/26/2024
• Device Model Number: 01.32.3248HCT
• Device Catalogue Number: 01.32.3248HCT
• Device Lot Number: 1909324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/17/2020
• 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: 67 YR
• Patient Weight: 84