MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P STD SIZE 2; FEMORAL STEM

Catalog Number	01.18.402
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 may 2021: lot 182522: (b)(4) items manufactured and released on 24-jul-2018.Expiration date: 2023-07-09.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.Another devices involved: batch review performed on 03 may 2021: liner: versafitcup cc trio 01.26.3644hct flat pe hc liner ø 36 / e (k103352) lot 147767: (b)(4) items manufactured and released on 12-mar-2015.Expiration date: 2020-02-29.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.Ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115)lot 1900802: (b)(4) items manufactured and released on 08-mag-2019.Expiration date: 2024-04-21.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
The patient came in reporting pain and instability due to a leg length discrepancy.The patient's operated leg was longer than then non-operated leg.The patient had pelvic obliquity issues and on x-rays the legs looked equal, but clinically the patient was long on the operated side.1 year and 8 months after primary the surgeon revised successfully the patient stem, head and liner.

• Brand Name: STEM: AMISTEM P STD SIZE 2
• Common Device Name: FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11862763
• Report Number: 3005180920-2021-00407
• Device Sequence Number: 3202634
• Product Code: LZO
• UDI-Device Identifier: 07630040720014
• UDI-Public: 07630040720014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2023
• Device Catalogue Number: 01.18.402
• Device Lot Number: 182522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/21/2021
• 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: Required Intervention