MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ACETABULAR SHELL CC TRIO NO-HOLE 56; HIP UNCEMENTED SHELL

Model Number	01.26.45.1156
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department: lot 144710: 100 items manufactured and released on 20-oct-2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2016.Additional devices involved: batch reviews performed by medacta regulatory affairs department liner: versafitcup cc trio 01.26.3248hct flat pe hc liner ø 32 / f (k103352) lot 135621: (b)(4) items manufactured and released on 16-jan-2014.Expiration date: 2018-11-31.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 since 2016.Stem: amistem h 01.18.134 ha coated std stem size 4 (k093944) lot 141466: (b)(4) items manufactured and released on 17-jan-2014.Expiration date: 2019-04-30.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 since 2016.Clinical evaluation performed by medacta medical affairs director: hip revision surgery performed 6 years after cementless total hip arthroplasty in a young man ((b)(6) year old) due to pain and instability.No information concerning patient general health status and activity level is available.Radiographic images provided show a suboptimal acetabular component position and pedestal formation at the tip of the stem.The cup position may be the cause for pain and instability but the reason of this position is not known: patient preoperative anatomy or bone morphology may be one reason but this cannot be assessed on the basis of prerevision x-rays.The reason of this event cannot be determined.
Event or Problem Description
Hip revision surgery 5 years and 10 months after the primary surgery due to pain and instability feeling while the patient walking due to cup anteversion.All the implants have been removed successfully and competitor's products implanted.

• Brand Name: ACETABULAR SHELL CC TRIO NO-HOLE 56
• Common Device Name: HIP UNCEMENTED SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10599607
• Report Number: 3005180920-2020-00654
• Device Sequence Number: 17048936
• Product Code: LZO
• UDI-Device Identifier: 07630030807916
• UDI-Public: 07630030807916
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 09/29/2020

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: 09/30/2019
• Device Model Number: 01.26.45.1156
• Device Catalogue Number: 01.26.45.1156
• Device Lot Number: 144710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/29/2020
• 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: 51 YR