MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES; HIP ACETABULAR SHELL

Model Number	01.32.154DH
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 february 2020: lot 135867: (b)(4) items manufactured and released on 07-aug-2014.Expiration date: 2019-06-30.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.Additional device involved.Batch review performed on 11 february 2020: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 152616: (b)(4) items manufactured and released on 13-oct-2015.Expiration date: 2020-09-30.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.Liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot 153133: (b)(4) items manufactured and released on 08-oct-2015.Expiration date: 2020-09-19.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 medacta medical affairs director: partial hip revision (cup, head and liner) performed 4 years and 2 months after total hip arthroplasty.No information concerning patient age, activity level and general health status is available.Poor quality of radiographic image provided doesn't allow a proper clinical evaluation and we are unable to determine why the stem was left in place and the cup removed.No conclusion can be drawn on the basis of evidence collected.
Event or Problem Description
The patient came in reporting pain, the cause of the pain is unknown.The surgeon revised the cup, head, and liner 4 years and 1 month after primary.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9785161
• Report Number: 3005180920-2020-00126
• Device Sequence Number: 2573956
• Product Code: LPH
• UDI-Device Identifier: 07630030810824
• UDI-Public: 07630030810824
• 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: 2015
• 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): 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 01.32.154DH
• Device Catalogue Number: 01.32.154DH
• Device Lot Number: 135867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 03/04/2020
• 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