MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 MULTI-HOLE

Model Number	01.32.154MH
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 5 june 2020: lot 153878: (b)(4) items manufactured and released on 11-jan-2016.Expiration date: 2020-12-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event.Additional implant involved: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.176831.Batch review performed by medacta regulatory affairs department on 5 june 2020: lot 176831: (b)(4) items manufactured and released on 05-mar-2018.Expiration date: 2023-02-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event.Additional implant involved: liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot.179363.Batch review performed by medacta regulatory affairs department on 5 june 2020: lot 179363: (b)(4) items manufactured and released on 05-apr-2018.Expiration date: 2023-03-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event.
Event or Problem Description
The patient came in 1 year and 10 months after the primary surgery reporting a leg length discrepancy.The surgeon revised the 36mm biolox head with a 28mm biolox head and revised the medacta cup and liner with another company's cup and liner.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø54 MULTI-HOLE
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10183414
• Report Number: 3005180920-2020-00350
• Device Sequence Number: 909099
• Product Code: LPH
• UDI-Device Identifier: 07630030810831
• UDI-Public: 07630030810831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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: 12/15/2020
• Device Model Number: 01.32.154MH
• Device Catalogue Number: 01.32.154MH
• Device Lot Number: 153878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/23/2020
• 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