MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 48 MULTI-HOLE; CUP: MPACT ACETABULAR SHELL MULTI-HOLE

Model Number	01.32.148MH
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 december 2020: lot 2003373: (b)(4) items manufactured and released on 10-jul-2020.Expiration date: 2025-07-08.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 device involved: batch review performed on 18 december 2020:liner: mpact 01.32.3239hct flat pe hc liner ¿32/c (k103721)lot.2001302.Lot 2001302: (b)(4) items manufactured and released on 12-may-2020.Expiration date: 2025-04-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported even.Batch review performed on 18 december 2020:liner: mpact 01.32.3239hct flat pe hc liner ¿32/c (k103721)lot.1908276: lot 1908276: (b)(4) items manufactured and released on 15-oct-2019.Expiration date: 2024-10-01.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
After inserting mpact 48mm at the patient acetabular, the surgeon tried to engage mpact liner with mpact cup, but the surgeon was not able to.The surgeon checked the inside and the outside of the mpact cup and tried to engage the same mpact liner, but the surgeon was not able to.The surgeon replaced with a new mpact liner which was the same reference and the different lot, but the surgeon was not able to engage again.The surgeon finally replaced it with a new mpact cup 50mm and a new liner.Replaced mpact liner was able to engage with replaced mpact cup as usual.Total surgery time was about 2 hours with 45minutes of delay.
Additional Manufacturer Narrative
On january 19th 2021, it was requested the analysis of the measures of the items involved in the complaint.R&d project manager analysis based on the measures received: additional visual inspection after quality control analysis.From the received controls, it appeared that the cup was totally conform to the specifications, while the pe liners were slightly out of tolerance for some dimensions, related to diameters and height.The reason related to this dimensions is probably related to the effects of the sterilization after implants, but from the received information it is not clear the certainty and the type of sterilization applied to the pieces.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d department : from the received pieces apparently, no particular deformation or detects were noticed.Moreover, an investigation was performed, revealing a correct insertion of the liner.From the analysis of the received pieces, it is not possible to determine with certainty the root cause of the event, but a possible reason can be related to an incorrect alignment or to a presence of interference body/liquids.

• Brand Name: CUP: MPACT ACETABULAR SHELL 48 MULTI-HOLE
• Common Device Name: CUP: MPACT ACETABULAR SHELL MULTI-HOLE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11115884
• Report Number: 3005180920-2021-00010
• Device Sequence Number: 3415846
• Product Code: LPH
• UDI-Device Identifier: 07630030810749
• UDI-Public: 07630030810749
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2025
• Device Model Number: 01.32.148MH
• Device Catalogue Number: 01.32.148MH
• Device Lot Number: 2003373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/08/2020; 12/08/2020
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/12/2021; 02/18/2021
• 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: Other